Childhood CancerMACSNCT04847908
The Munich Adrenaline Cancer Study
A study testing Single high-intensity interval exercise intervention in people with Childhood Cancer, run by Technical University of Munich at 1 site in Germany.
Trial summary
Observational studies report associations between physical activity and survival in some types of adult cancer. In addition, some exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Single high-intensity interval exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 31 May 2021
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- newly diagnosed pediatric cancer or relapse
- aged 6-18 years
- between the first and third cycle of chemotherapy
- diagnosis and treatment at the Kinderklinik München Schwabing, Department of Paediatrics and Children's Cancer Research Centre, Technical University of Munich
- German language
- informed consent as documented by signature
Who cannot join
- Any medical contraindication with respect to a high-intensity interval exercise intervention (e.g., cardiovascular complications, comorbidities, bleeding risk, pain, infection, nausea, orthopedic impairment of the lower extremities)
- inability to follow the procedures and understand the intervention and assessment of the study, e.g., due to cognitive impairment, language problems, psychological disorders etc.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kinderklinik München Schwabing, TUM School of Medicine, Department of Paediatrics and Children's Cancer Research Center, Technical University of Munich, Germany
Munich, 80804
About this study
Official title: Changes in Metabolite Concentrations After a Single High-intensity Interval Exercise Intervention During Treatment for Childhood Cancer - A Pilot Study
Observational studies report associations between physical activity and survival in some types of adult cancer. In addition, some exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this study is to analyse changes in adrenaline concentration with a single high-intensity interval exercise intervention on a cycle ergometer in children and adolescents during treatment for cancer and to examine the feasibility of the study concept.
Read the detailed description
Exercise is generally recommended as an adjunct therapy for adult cancer patients as it counteracts the adverse effects of cancer and its treatment. According to epidemiological data, exercise is also associated with a reduced risk of tumour developement and an improval of survival in some tumours. However, the underlying mechanisms by which exercise affects tumour cells are poorly understood in adult cancer patients and mostly unknown in children. Recent studies demonstrate anti-cancer effects of exercise-induced adrenaline through natural killer cell mobilisation and Hippo signalling. In addition, several exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this pilot study is the analysation of exercise-induced changes in adrenaline concentration in childhood cancer patients and to show feasibility of the study concept. Following recruitment within the first and third cycle of chemotherapy and consent for study participation, all recruited patients perform a single high-intensity interval exercise intervention on a cycle ergometer. Intensity of the intervals is examined both subjectively via a scale for rate of perceived exertion and objectively via changes in lactate concentration pre- and post-exercise as well as heart rate monitoring. Blood samples are taken by trained personnel staff and prepared for processing (centrifuged, snap-frozen). Changes in adrenaline concentration are measured with a commercial ELISA kit. For further identification of metabolites that change with exercise, a non-biased mass spectrometry metabolomics analysis will be used.
- Conditions
- Childhood Cancer
- Being tested
- Single high-intensity interval exercise intervention
- Keywords
- exercise, metabolomics, high-intensity interval exercise intervention
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single high-intensity interval exercise interventionOther
Study participants perform a single bout of exercise on a cycle ergometer (high-intensity interval exercise intervention) within the first and third cycle of chemotherapy. Following a 2 minute warm-up, the interval protocol comprises 10 intervals à 15 seconds with high intensity and 60 seconds low intensity in-between. Blood samples are taken at t0 pre-exercise (after a 10 minute rest) and at t1 immediately post-exercise via central catheter (Hickman/port).
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval exercise intervention | Experimental | Change according to definition. Receives: Other: Single high-intensity interval exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in adrenaline concentration
Blood samples are collected at rest pre-exercise (t0) and post-exercise (t1) via a central catheter and prepared for processing by trained personnel (centrifuged, snap-frozen). Both at t0 and t1, 4,9ml blood are taken for adrenaline and lactate concentration (see secondary outcomes). Serum adrenaline concentration is measured with an ELISA kit in mmol/l.
Measured: Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1)
Secondary outcomes (4)
Feasibility of the study concept
Feasibility of the study concept is examined via compliance, acceptance and safety.
Detailed documentation ensures completeness of feasibility aspects.
Measured: Through study completion, on average 14 days
Lactate concentration
Lactate concentration is analysed to examine the level of intensity of the single high-intensity interval exercise intervention. Blood samples are collected at rest pre-exercise (t0) and post-exercise (t1), both 4,9ml, via a central catheter and prepared for processing by trained personnel. Lactate concentration is measured with Biosen C-Line in mmol/l.
Measured: Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1)
Heart rate
Heart rate monitoring is used to objectively measure the level of intensity during the single high-intensity interval exercise intervention for safety monitoring. Heart rate levels are documented at rest pre-exercise, after every interval and post-exercise.
Measured: Pre-exercise (at rest, t0), during high-intensity interval exercise intervention and post-exercise (within 3 min, t1)
Physical activity before diagnosis
Physical activity levels are investigated using a standardised questionnaire (ActiOn) to evaluate the extent, range and intensity of physical activity shortly before the diagnosis. This questionnaire was developed for children and adolescents during and after treatment for childhood cancer.
Measured: Once, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Mar 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Helmholtz Zentrum München
- Responsible party
- Principal investigator, Sabine Kesting, Technical University of Munich
- Investigators
- Irene Teichert-von Lüttichau, PD Dr. med., Principal investigator, TUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847908
- Sponsor's protocol ID
- TUM
- Acronym
- MACS
- Status last verified
- Oct 2021
- First submitted
- 31 Mar 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Metabolite Concentrations After a Single High-intensity Interval Exercise Intervention During Treatment for Childhood Cancer - A Pilot Study
- ClinicalTrials.gov ID
- NCT04847908
- Acronym / sponsor ID
- MACS / TUM
- Conditions
- Childhood Cancer
- Keywords
- exercise, metabolomics, high-intensity interval exercise intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Helmholtz Zentrum München
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 19 Apr 2021 (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.
Observational studies report associations between physical activity and survival in some types of adult cancer. In addition, some exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this study is to analyse changes in adrenaline concentration with a single high-intensity interval exercise intervention on a cycle ergometer in children and adolescents during treatment for cancer and to examine the feasibility of the study concept.
Detailed description
Exercise is generally recommended as an adjunct therapy for adult cancer patients as it counteracts the adverse effects of cancer and its treatment. According to epidemiological data, exercise is also associated with a reduced risk of tumour developement and an improval of survival in some tumours. However, the underlying mechanisms by which exercise affects tumour cells are poorly understood in adult cancer patients and mostly unknown in children. Recent studies demonstrate anti-cancer effects of exercise-induced adrenaline through natural killer cell mobilisation and Hippo signalling. In addition, several exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this pilot study is the analysation of exercise-induced changes in adrenaline concentration in childhood cancer patients and to show feasibility of the study concept. Following recruitment within the first and third cycle of chemotherapy and consent for study participation, all recruited patients perform a single high-intensity interval exercise intervention on a cycle ergometer. Intensity of the intervals is examined both subjectively via a scale for rate of perceived exertion and objectively via changes in lactate concentration pre- and post-exercise as well as heart rate monitoring. Blood samples are taken by trained personnel staff and prepared for processing (centrifuged, snap-frozen). Changes in adrenaline concentration are measured with a commercial ELISA kit. For further identification of metabolites that change with exercise, a non-biased mass spectrometry metabolomics analysis will be used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval exercise intervention | Experimental | Other: Single high-intensity interval exercise interventionChange according to definition. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- newly diagnosed pediatric cancer or relapse
- aged 6-18 years
- between the first and third cycle of chemotherapy
- diagnosis and treatment at the Kinderklinik München Schwabing, Department of Paediatrics and Children's Cancer Research Centre, Technical University of Munich
- German language
Key exclusion criteria (2 listed)
- Any medical contraindication with respect to a high-intensity interval exercise intervention (e.g., cardiovascular complications, comorbidities, bleeding risk, pain, infection, nausea, orthopedic impairment of the lower extremities)
- inability to follow the procedures and understand the intervention and assessment of the study, e.g., due to cognitive impairment, language problems, psychological disorders etc.
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 |
|---|---|---|
| Single high-intensity interval exercise interventionStudy participants perform a single bout of exercise on a cycle ergometer (high-intensity interval exercise intervention) within the first and third cycle of chemotherapy. Following a 2 minute warm-up, the interval protocol comprises 10 intervals à 15 seconds with high intensity and 60 seconds low intensity in-between. Blood samples are taken at t0 pre-exercise (after a 10 minute rest) and at t1 immediately post-exercise via central catheter (Hickman/port). | Other | High-intensity interval exercise intervention |
Primary outcome
Changes in adrenaline concentration
Time frame: Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1)
Blood samples are collected at rest pre-exercise (t0) and post-exercise (t1) via a central catheter and prepared for processing by trained personnel (centrifuged, snap-frozen). Both at t0 and t1, 4,9ml blood are taken for adrenaline and lactate concentration (see secondary outcomes). Serum adrenaline concentration is measured with an ELISA kit in mmol/l.
4 secondary outcomes
Feasibility of the study concept
Time frame: Through study completion, on average 14 days
Lactate concentration
Time frame: Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1)
Heart rate
Time frame: Pre-exercise (at rest, t0), during high-intensity interval exercise intervention and post-exercise (within 3 min, t1)
Physical activity before diagnosis
Time frame: Once, pre-intervention
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 26 Oct 2021.
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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.
Irene Teichert-von Lüttichau, PD Dr. med. principal investigator
TUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single high-intensity interval exercise intervention in people with Childhood Cancer, run by Technical University of Munich at 1 site in Germany.
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 6 inclusion and 2 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 26 Oct 2021. 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 Germany. 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?
Changes in adrenaline concentration (time frame: Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2021.