MelanomaAgilityNCT05615883
Effects of Acute and Chronic Exercise on Myeloid-Derived Suppressor Cells in Melanoma Patients
A study testing AEP Group Walking Sessions and CEP Group Walking Sessions in people with Melanoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
This study is designed to investigate the effects of ketogenic milieu induced by acute exercise as well as the effects of recurrent exercise bouts on functional status and the accumulation in peripheral blood of MDSCs and the consequent balance on antitumor immunity in melanoma patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Melanoma
- What is being tested?
- AEP Group Walking Sessions and CEP Group Walking Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years at the time of recruitment
- Histologically confirmed diagnosis of primary melanoma
- Patients who are candidate to curative surgery for primary melanoma, skin radicalization or sentinel node biopsy.
- American Society of Anaesthesiologists (ASA) status I
- Willingness and ability to comply with the protocol, the scheduled visits, treatment plans, laboratory tests and other procedures.
- Understanding and signature of the informed consent
- Female patients of childbearing potential must agree to sexual abstinence or to use highly effective method of contraception throughout the study (for CEP patients)
Who cannot join
- American Society of Anaesthesiologists (ASA) status > I
- Pregnancy or lactation
- Known infection from HIV virus
- Regular physical exercise (more than 1 exercise workout of moderate to intense exercise activity per week)
- Any physical or mental conditions interfering with the ability to perform exercise or to complete the testing procedures.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to investigate the effects of ketogenic milieu induced by acute exercise as well as the effects of recurrent exercise bouts on functional status and the accumulation in peripheral blood of MDSCs and the consequent balance on antitumor immunity in melanoma patients.
Read the detailed description
The screening period starts once a patient has provided written informed consent to participate in the study and ends on the day of exercise initiation. Screening assessments have to be done within 28 days prior to exercise initiation. The informed consent will adhere to IRB/ERC requirements, applicable laws and regulations. After the sign of an informed consensus, patients will be assigned to a specific exercise program. The first series of patients will be assigned to the Acute Exercise Program (AEP group), the second series to the Chronic Exercise Program (CEP group). The protocol will be implemented in the time between diagnosis and surgical intervention without any delay in the therapeutic pathway.
Basal evaluation: patient's life style will be investigated using the short version of Physical Activity Questionnaire (Italian version) and MeDiet questionnaire. Age, weight and eight will be registered for all patients. The Lean Body Mass will be measured by Dual Energy X-ray Absorptiometry (DEXA). A cardiorespiratory test will be performed to calculate an appropriate exercise intensity and subsequently the Six Minutes WalkingTest and the Comfortable Walking Speed test will be run before exercise protocol. In the CEP group the DEXA and the walking tests will be repeated after the end of exercise program.
Exercise prescription: the physical exercise consists in walking at a brisk pace. In order to produce a constant metabolic stress in patients with different aerobic power, walking intensity will be prescribed in accordance with the method of the Heart Rate Reserve (HRR), ie difference between resting heart rate (HR-resting) and the heart rate corresponding to muscle's maximal oxygen uptake (HR-max). This prescribing method is based on the linear relationship between heart rate reserve and muscle workload calculated as a percentage of the difference between resting and maximum muscle oxygen consumption (VO2R%). The training intensity will be set to the 30% HRR, the lowest intensity that produces a training effect. To minimize the impact of the research protocol on the patient's therapeutic path, the investigators refrain from the execution of a Cardio Pulmonary Exercise Test and therefore opted for calculating the HR-max using the ACSM formula. Given the entry criteria of this study the investigators believe this choice will minimally affect the exercise-dose prescription and study results.
Acute Exercise Protocol (AEP): The acute program consists in a single walking session on a treadmill lasting 80 minutes. The exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, treadmill speed will be increased until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner 35) and the walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).
Chronic Exercise Protocol (CEP): The chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks. The walking intensity will be defined during a treadmill test performed before the beginning of the exercise program. Each exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, patients will increase treadmill speed until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. The first training session will be organized in hospital with supervision of research staff. Cardiac workload will be monitored by a Sport-watch(Garmin Forerunner 35) and walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).
Diet intervention: Modifications occurring during AEP strictly depend on the baseline metabolic conditions. For this reason, patients must remain fasting for 4 hours before the workout and avoid glucose rich foodies for 120 minutes after the end of exercise session in CEP group. During the exercise session patients will have free access to water only. All patients will complete a food diary during the study period.
- Conditions
- Melanoma
- Being tested
- AEP Group Walking Sessions, CEP Group Walking Sessions
- Keywords
- Primary Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEP Group Walking SessionsOther
The AEP Program consists in a single walking session on a treadmill lasting 80 minutes
CEP Group Walking SessionsOther
The chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| AEP Group | Experimental | First series of patients (10 pts) will be assigned to the Acute Exercise Protocol Group (AEP Group). The acute program consists in a single walking session on a treadmill lasting 80 minutes. The exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, treadmill speed will be increased until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner) and the walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore). Receives: Other: AEP Group Walking Sessions |
| CEP Group | Experimental | Second series of patients (10 pts) will be assigned to the Chronic Exercise Protocol Group (CEP Group). The chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks. The walking intensity will be defined during a treadmill test performedbefore the beginning of the exercise program. Each exercise session will beginwith a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, patients will increase treadmill speed until reaching target HRR zone.Then the treadmill speed will be maintained stable throughout the exercise session. The first training session will be organized in hospital with supervision of research staff. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner) and walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore). Receives: Other: CEP Group Walking Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Measured: AEP group: before exercise session.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Measured: AEP group: after 40 minutes of exercise session.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Measured: AEP group: after 80 minutes of exercise session.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Measured: AEP group: at 24 post-exercise.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Measured: AEP group: at 72 hours post-exercise.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Measured: CEP group: before exercise program.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Measured: CEP group: after one week of exercise program.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Measured: CEP group: up to two weeks of exercise program.
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Measured: AEP group: before exercise.
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Measured: AEP group: after 40 minutes of exercise session
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Measured: AEP group: after 80 minutes of exercise session.
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Measured: AEP group: at 24 post-exercise.
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Measured: AEP group: at 72 hours post-exercise.
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Measured: CEP group: before exercise program.
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Measured: CEP group: after one week of exercise program.
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Measured: CEP group: up to two weeks of exercise program.
Analysis of the "systemic metabolic milieu"_AEPMet before
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Measured: AEP group: before exercise.
Analysis of the "systemic metabolic milieu"_AEPHor before
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Measured: AEP group: before exercise.
Analysis of the "systemic metabolic milieu"_AEPInf before
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Measured: AEP group: before exercise.
Analysis of the "systemic metabolic milieu"_AEPLip before
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Measured: AEP group: before exercise.
Analysis of the "systemic metabolic milieu"_AEPcounts before
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Measured: AEP group: before exercise.
Analysis of the "systemic metabolic milieu"_AEPMet 40
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Measured: AEP group: after 40 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPHor 40
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Measured: AEP group: after 40 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPInf 40
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Measured: AEP group: after 40 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPLip 40
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Measured: AEP group: after 40 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPcounts 40
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Measured: AEP group: after 40 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPMet 80
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Measured: AEP group: after 80 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPHor 80
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Measured: AEP group: after 80 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPInf 80
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Measured: AEP group: after 80 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPLip 80
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Measured: AEP group: after 80 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPcounts 80
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Measured: AEP group: after 80 minutes of exercise session.
Analysis of the "systemic metabolic milieu"_AEPMet 24
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Measured: AEP group: at 24 post-exercise.
Analysis of the "systemic metabolic milieu"_AEPHor 24
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Measured: AEP group: at 24 post-exercise.
Analysis of the "systemic metabolic milieu"_AEPInf 24
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Measured: AEP group: at 24 post-exercise.
Analysis of the "systemic metabolic milieu"_AEPLip 24
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Measured: AEP group: at 24 post-exercise.
Analysis of the "systemic metabolic milieu"_AEPcounts 24
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Measured: AEP group: at 24 post-exercise.
Analysis of the "systemic metabolic milieu"_AEPMet 72
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Measured: AEP group: at 72 hours post-exercise.
Analysis of the "systemic metabolic milieu"_AEPHor 72
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Measured: AEP group: at 72 hours post-exercise.
Analysis of the "systemic metabolic milieu"_AEPInf 72
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Measured: AEP group: at 72 hours post-exercise.
Analysis of the "systemic metabolic milieu"_AEPLip 72
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Measured: AEP group: at 72 hours post-exercise.
Analysis of the "systemic metabolic milieu"_AEPcounts 72
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Measured: AEP group: at 72 hours post-exercise.
Analysis of the "systemic metabolic milieu"_CEPMet before
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Measured: CEP group: before exercise program.
Analysis of the "systemic metabolic milieu"_CEPHor before
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Measured: CEP group: before exercise program.
Analysis of the "systemic metabolic milieu"_CEPInf before
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Measured: CEP group: before exercise program.
Analysis of the "systemic metabolic milieu"_CEPLip before
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Measured: CEP group: before exercise program.
Analysis of the "systemic metabolic milieu"_CEP counts before
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Measured: CEP group: before exercise program.
Analysis of the "systemic metabolic milieu"_CEPMet 1w
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Measured: CEP group: after one week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPHor 1w
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Measured: CEP group: after one week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPInf 1w
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Measured: CEP group: after one week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPLip 1w
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Measured: CEP group: after one week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPcounts 1w
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Measured: CEP group: after one week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPMet 2w
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Measured: CEP group: up to two week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPHor 2w
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Measured: CEP group: up to two week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPInf 2w
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Measured: CEP group: up to two week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPLip 2w
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Measured: CEP group: up to two week of exercise program.
Analysis of the "systemic metabolic milieu"_CEPcounts 2w
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Measured: CEP group: up to two week of exercise program.
Analysis of the metabolic parameters by capillary sampling_AEPCap before
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Measured: AEP group: before exercise session.
Analysis of the metabolic parameters by capillary sampling_AEPCap 40
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Measured: AEP group: after 40 minutes of exercise session.
Analysis of the metabolic parameters by capillary sampling_AEPCap 80
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Measured: AEP group: after 80 minutes of exercise session.
Analysis of the metabolic parameters by capillary sampling_AEPCap 24
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Measured: AEP group: at 24 post-exercise.
Analysis of the metabolic parameters by capillary sampling_AEPCap 72
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Measured: AEP group: at 72 hours post-exercise.
Analysis of the metabolic parameters by capillary sampling_CEPCap before
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Measured: CEP group: during the first training session
Analysis of the metabolic parameters by capillary sampling_CEPCap 2w
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Measured: CEP group: every morning up to two weeks.
Analysis of the metabolic parameters by capillary sampling_CEPCap end
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Measured: CEP group: at the end of training sessions up to two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start20 Jan 2020
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Pre/post intervention, two-arms, sequential study. Patients with newly diagnose of melanoma are eligible.The study will enroll a total of 20 patients (10 in the AEP and 10 in the CEP), who will be enrolled approximately in 12-13 months.The first series of patients will be assigned to the Acute Exercise Program (AEP group), the second series to the Chronic Exercise Program (CEP group). The final endpoint is to verify whether short-term physical exercise can represent a feasible and safe tool for re-setting antitumor immunity in early melanoma patients. Investigators will analyze how the acute physical exercise modifies systemic immunity and biochemical/metabolic parameters. Specifically, Investigators will verify whether the exercise will modify:1 the immunological profiling of blood including frequency and function of MDSC, together with the concomitant status of antitumor immunity; 2 blood concentration of biochemical and metabolic parameters related to physical exercise and immunity
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Licia Rivoltini, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615883
- Sponsor's protocol ID
- INT 148/19
- Other IDs
- IG 2017 Project n. 20752
- Acronym
- Agility
- Status last verified
- Sep 2022
- First submitted
- 29 Apr 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the study data could be compared with those obtained from other clinical studies, focused on the immune system, this part is not yet defined. Anyhow it will depend on the results obtained.
Publications
Yuan HX, Xiong Y, Guan KL. Nutrient sensing, metabolism, and cell growth control. Mol Cell. 2013 Feb 7;49(3):379-87. doi: 10.1016/j.molcel.2013.01.019.
PubMed 23395268Dazert E, Hall MN. mTOR signaling in disease. Curr Opin Cell Biol. 2011 Dec;23(6):744-55. doi: 10.1016/j.ceb.2011.09.003. Epub 2011 Sep 29.
PubMed 21963299Buck MD, Sowell RT, Kaech SM, Pearce EL. Metabolic Instruction of Immunity. Cell. 2017 May 4;169(4):570-586. doi: 10.1016/j.cell.2017.04.004.
PubMed 28475890Biswas SK. Metabolic Reprogramming of Immune Cells in Cancer Progression. Immunity. 2015 Sep 15;43(3):435-49. doi: 10.1016/j.immuni.2015.09.001.
PubMed 26377897Longo VD, Mattson MP. Fasting: molecular mechanisms and clinical applications. Cell Metab. 2014 Feb 4;19(2):181-92. doi: 10.1016/j.cmet.2013.12.008. Epub 2014 Jan 16.
PubMed 24440038Filipazzi P, Huber V, Rivoltini L. Phenotype, function and clinical implications of myeloid-derived suppressor cells in cancer patients. Cancer Immunol Immunother. 2012 Feb;61(2):255-263. doi: 10.1007/s00262-011-1161-9. Epub 2011 Nov 27.
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PubMed 7928844
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute and Chronic Exercise on Myeloid-Derived Suppressor Cells in Melanoma Patients
- ClinicalTrials.gov ID
- NCT05615883
- Acronym / sponsor ID
- Agility / INT 148/19
- Conditions
- Melanoma
- Keywords
- Primary Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the effects of ketogenic milieu induced by acute exercise as well as the effects of recurrent exercise bouts on functional status and the accumulation in peripheral blood of MDSCs and the consequent balance on antitumor immunity in melanoma patients.
Detailed description
The screening period starts once a patient has provided written informed consent to participate in the study and ends on the day of exercise initiation. Screening assessments have to be done within 28 days prior to exercise initiation. The informed consent will adhere to IRB/ERC requirements, applicable laws and regulations. After the sign of an informed consensus, patients will be assigned to a specific exercise program. The first series of patients will be assigned to the Acute Exercise Program (AEP group), the second series to the Chronic Exercise Program (CEP group). The protocol will be implemented in the time between diagnosis and surgical intervention without any delay in the therapeutic pathway.
Basal evaluation: patient's life style will be investigated using the short version of Physical Activity Questionnaire (Italian version) and MeDiet questionnaire. Age, weight and eight will be registered for all patients. The Lean Body Mass will be measured by Dual Energy X-ray Absorptiometry (DEXA). A cardiorespiratory test will be performed to calculate an appropriate exercise intensity and subsequently the Six Minutes WalkingTest and the Comfortable Walking Speed test will be run before exercise protocol. In the CEP group the DEXA and the walking tests will be repeated after the end of exercise program.
Exercise prescription: the physical exercise consists in walking at a brisk pace. In order to produce a constant metabolic stress in patients with different aerobic power, walking intensity will be prescribed in accordance with the method of the Heart Rate Reserve (HRR), ie difference between resting heart rate (HR-resting) and the heart rate corresponding to muscle's maximal oxygen uptake (HR-max). This prescribing method is based on the linear relationship between heart rate reserve and muscle workload calculated as a percentage of the difference between resting and maximum muscle oxygen consumption (VO2R%). The training intensity will be set to the 30% HRR, the lowest intensity that produces a training effect. To minimize the impact of the research protocol on the patient's therapeutic path, the investigators refrain from the execution of a Cardio Pulmonary Exercise Test and therefore opted for calculating the HR-max using the ACSM formula. Given the entry criteria of this study the investigators believe this choice will minimally affect the exercise-dose prescription and study results.
Acute Exercise Protocol (AEP): The acute program consists in a single walking session on a treadmill lasting 80 minutes. The exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, treadmill speed will be increased until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner 35) and the walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).
Chronic Exercise Protocol (CEP): The chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks. The walking intensity will be defined during a treadmill test performed before the beginning of the exercise program. Each exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, patients will increase treadmill speed until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. The first training session will be organized in hospital with supervision of research staff. Cardiac workload will be monitored by a Sport-watch(Garmin Forerunner 35) and walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).
Diet intervention: Modifications occurring during AEP strictly depend on the baseline metabolic conditions. For this reason, patients must remain fasting for 4 hours before the workout and avoid glucose rich foodies for 120 minutes after the end of exercise session in CEP group. During the exercise session patients will have free access to water only. All patients will complete a food diary during the study period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre/post intervention, two-arms, sequential study. Patients with newly diagnose of melanoma are eligible.The study will enroll a total of 20 patients (10 in the AEP and 10 in the CEP), who will be enrolled approximately in 12-13 months.The first series of patients will be assigned to the Acute Exercise Program (AEP group), the second series to the Chronic Exercise Program (CEP group). The final endpoint is to verify whether short-term physical exercise can represent a feasible and safe tool for re-setting antitumor immunity in early melanoma patients. Investigators will analyze how the acute physical exercise modifies systemic immunity and biochemical/metabolic parameters. Specifically, Investigators will verify whether the exercise will modify:1 the immunological profiling of blood including frequency and function of MDSC, together with the concomitant status of antitumor immunity; 2 blood concentration of biochemical and metabolic parameters related to physical exercise and immunity
| Arm | Type | Receives |
|---|---|---|
| AEP Group | Experimental | Other: AEP Group Walking SessionsFirst series of patients (10 pts) will be assigned to the Acute Exercise Protocol Group (AEP Group). The acute program consists in a single walking session on a treadmill lasting 80 minutes. The exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, treadmill speed will be increased until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner) and the walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore). |
| CEP Group | Experimental | Other: CEP Group Walking SessionsSecond series of patients (10 pts) will be assigned to the Chronic Exercise Protocol Group (CEP Group). The chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks. The walking intensity will be defined during a treadmill test performedbefore the beginning of the exercise program. Each exercise session will beginwith a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, patients will increase treadmill speed until reaching target HRR zone.Then the treadmill speed will be maintained stable throughout the exercise session. The first training session will be organized in hospital with supervision of research staff. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner) and walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 65 years at the time of recruitment
- Histologically confirmed diagnosis of primary melanoma
- Patients who are candidate to curative surgery for primary melanoma, skin radicalization or sentinel node biopsy.
- American Society of Anaesthesiologists (ASA) status I
- Willingness and ability to comply with the protocol, the scheduled visits, treatment plans, laboratory tests and other procedures.
Key exclusion criteria (5 listed)
- American Society of Anaesthesiologists (ASA) status > I
- Pregnancy or lactation
- Known infection from HIV virus
- Regular physical exercise (more than 1 exercise workout of moderate to intense exercise activity per week)
- Any physical or mental conditions interfering with the ability to perform exercise or to complete the testing procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AEP Group Walking SessionsThe AEP Program consists in a single walking session on a treadmill lasting 80 minutes | Other | AEP Group |
| CEP Group Walking SessionsThe chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks. | Other | CEP Group |
Primary outcome
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: before exercise session.
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: after 40 minutes of exercise session.
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: after 80 minutes of exercise session.
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: at 24 post-exercise.
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: at 72 hours post-exercise.
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: CEP group: before exercise program.
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: CEP group: after one week of exercise program.
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: CEP group: up to two weeks of exercise program.
Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: before exercise.
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: after 40 minutes of exercise session
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: after 80 minutes of exercise session.
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: at 24 post-exercise.
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: AEP group: at 72 hours post-exercise.
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: CEP group: before exercise program.
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: CEP group: after one week of exercise program.
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)
Time frame: CEP group: up to two weeks of exercise program.
CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).
Analysis of the "systemic metabolic milieu"_AEPMet before
Time frame: AEP group: before exercise.
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Analysis of the "systemic metabolic milieu"_AEPHor before
Time frame: AEP group: before exercise.
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Analysis of the "systemic metabolic milieu"_AEPInf before
Time frame: AEP group: before exercise.
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Analysis of the "systemic metabolic milieu"_AEPLip before
Time frame: AEP group: before exercise.
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Analysis of the "systemic metabolic milieu"_AEPcounts before
Time frame: AEP group: before exercise.
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Analysis of the "systemic metabolic milieu"_AEPMet 40
Time frame: AEP group: after 40 minutes of exercise session.
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Analysis of the "systemic metabolic milieu"_AEPHor 40
Time frame: AEP group: after 40 minutes of exercise session.
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Analysis of the "systemic metabolic milieu"_AEPInf 40
Time frame: AEP group: after 40 minutes of exercise session.
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Analysis of the "systemic metabolic milieu"_AEPLip 40
Time frame: AEP group: after 40 minutes of exercise session.
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Analysis of the "systemic metabolic milieu"_AEPcounts 40
Time frame: AEP group: after 40 minutes of exercise session.
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Analysis of the "systemic metabolic milieu"_AEPMet 80
Time frame: AEP group: after 80 minutes of exercise session.
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Analysis of the "systemic metabolic milieu"_AEPHor 80
Time frame: AEP group: after 80 minutes of exercise session.
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Analysis of the "systemic metabolic milieu"_AEPInf 80
Time frame: AEP group: after 80 minutes of exercise session.
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Analysis of the "systemic metabolic milieu"_AEPLip 80
Time frame: AEP group: after 80 minutes of exercise session.
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Analysis of the "systemic metabolic milieu"_AEPcounts 80
Time frame: AEP group: after 80 minutes of exercise session.
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Analysis of the "systemic metabolic milieu"_AEPMet 24
Time frame: AEP group: at 24 post-exercise.
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Analysis of the "systemic metabolic milieu"_AEPHor 24
Time frame: AEP group: at 24 post-exercise.
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Analysis of the "systemic metabolic milieu"_AEPInf 24
Time frame: AEP group: at 24 post-exercise.
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Analysis of the "systemic metabolic milieu"_AEPLip 24
Time frame: AEP group: at 24 post-exercise.
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Analysis of the "systemic metabolic milieu"_AEPcounts 24
Time frame: AEP group: at 24 post-exercise.
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Analysis of the "systemic metabolic milieu"_AEPMet 72
Time frame: AEP group: at 72 hours post-exercise.
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Analysis of the "systemic metabolic milieu"_AEPHor 72
Time frame: AEP group: at 72 hours post-exercise.
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Analysis of the "systemic metabolic milieu"_AEPInf 72
Time frame: AEP group: at 72 hours post-exercise.
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Analysis of the "systemic metabolic milieu"_AEPLip 72
Time frame: AEP group: at 72 hours post-exercise.
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Analysis of the "systemic metabolic milieu"_AEPcounts 72
Time frame: AEP group: at 72 hours post-exercise.
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Analysis of the "systemic metabolic milieu"_CEPMet before
Time frame: CEP group: before exercise program.
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Analysis of the "systemic metabolic milieu"_CEPHor before
Time frame: CEP group: before exercise program.
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Analysis of the "systemic metabolic milieu"_CEPInf before
Time frame: CEP group: before exercise program.
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Analysis of the "systemic metabolic milieu"_CEPLip before
Time frame: CEP group: before exercise program.
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Analysis of the "systemic metabolic milieu"_CEP counts before
Time frame: CEP group: before exercise program.
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Analysis of the "systemic metabolic milieu"_CEPMet 1w
Time frame: CEP group: after one week of exercise program.
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Analysis of the "systemic metabolic milieu"_CEPHor 1w
Time frame: CEP group: after one week of exercise program.
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Analysis of the "systemic metabolic milieu"_CEPInf 1w
Time frame: CEP group: after one week of exercise program.
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Analysis of the "systemic metabolic milieu"_CEPLip 1w
Time frame: CEP group: after one week of exercise program.
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Analysis of the "systemic metabolic milieu"_CEPcounts 1w
Time frame: CEP group: after one week of exercise program.
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Analysis of the "systemic metabolic milieu"_CEPMet 2w
Time frame: CEP group: up to two week of exercise program.
In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters
Analysis of the "systemic metabolic milieu"_CEPHor 2w
Time frame: CEP group: up to two week of exercise program.
In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters
Analysis of the "systemic metabolic milieu"_CEPInf 2w
Time frame: CEP group: up to two week of exercise program.
In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters
Analysis of the "systemic metabolic milieu"_CEPLip 2w
Time frame: CEP group: up to two week of exercise program.
We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes
Analysis of the "systemic metabolic milieu"_CEPcounts 2w
Time frame: CEP group: up to two week of exercise program.
Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.
Analysis of the metabolic parameters by capillary sampling_AEPCap before
Time frame: AEP group: before exercise session.
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Analysis of the metabolic parameters by capillary sampling_AEPCap 40
Time frame: AEP group: after 40 minutes of exercise session.
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Analysis of the metabolic parameters by capillary sampling_AEPCap 80
Time frame: AEP group: after 80 minutes of exercise session.
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Analysis of the metabolic parameters by capillary sampling_AEPCap 24
Time frame: AEP group: at 24 post-exercise.
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Analysis of the metabolic parameters by capillary sampling_AEPCap 72
Time frame: AEP group: at 72 hours post-exercise.
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Analysis of the metabolic parameters by capillary sampling_CEPCap before
Time frame: CEP group: during the first training session
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Analysis of the metabolic parameters by capillary sampling_CEPCap 2w
Time frame: CEP group: every morning up to two weeks.
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Analysis of the metabolic parameters by capillary sampling_CEPCap end
Time frame: CEP group: at the end of training sessions up to two weeks.
Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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- Background: PubMed 27757311Trikha P, Plews RL, Stiff A, Gautam S, Hsu V, Abood D, Wesolowski R, Landi I, Mo X, Phay J, Chen CS, Byrd J, Caligiuri M, Tridandapani S, Carson W. Targeting myeloid-derived suppressor cells using a novel adenosine monophosphate-activated protein kinase (AMPK) activator. Oncoimmunology. 2016 Jul 25;5(9):e1214787. doi: 10.1080/2162402X.2016.1214787. eCollection 2016.
- Background: PubMed 29805099Li W, Tanikawa T, Kryczek I, Xia H, Li G, Wu K, Wei S, Zhao L, Vatan L, Wen B, Shu P, Sun D, Kleer C, Wicha M, Sabel M, Tao K, Wang G, Zou W. Aerobic Glycolysis Controls Myeloid-Derived Suppressor Cells and Tumor Immunity via a Specific CEBPB Isoform in Triple-Negative Breast Cancer. Cell Metab. 2018 Jul 3;28(1):87-103.e6. doi: 10.1016/j.cmet.2018.04.022. Epub 2018 May 24.
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- Individual participant dataSharing planned: No. Since the study data could be compared with those obtained from other clinical studies, focused on the immune system, this part is not yet defined. Anyhow it will depend on the results obtained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Licia Rivoltini, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AEP Group Walking Sessions and CEP Group Walking Sessions in people with Melanoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise) (time frame: AEP group: before exercise session.). The study lists 64 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05615883, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.