Breast NeoplasmsNCT03528473
Adapted Physical Activity (APA) in a Breast Cancer Population.
A study testing Exercise in people with Breast Neoplasms and Exercise, run by University Of Perugia at 1 site in Italy.
Trial summary
The aim of this study is to investigate the effect of a 6-months program of Adapted Physical Activity (APA) on lifestyle, physical activity levels, insulin resistance and adipokines, oxidative stress, microcirculatory haemodynamics and serum levels of specific circulating miRNA in post-menopausal, physically inactive… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms, Exercise, Exercise Therapy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 31 Dec 2022
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients in oncological follow-up
- post-menopausal age
- physically inactivity (light to moderate or vigorous leisure-time physical activity less than 10 minutes a day, US National Health Interview Survey)
- assuming or not hormone therapy
- after 3 months - 3 years from adjuvant post-surgical treatment (radiotherapy and/or chemotherapy)
Who cannot join
- Permanent
- Patients older than 80 years
- Inability to carry on physical activity
- Metastatic neoplasia or unknown stage and/or histology
- Concomitant neoplasia
- Patients on corticosteroid treatment
Show all 17Show fewer
- Known heart disease (heart failure NYHA II (New York Heart Association II) or superior, angina pectoris or positive exercise stress test, treatment-related cardiotoxicity)
- Currently on a weight loss plan or on moderate physical activity before the start of the project (no more than three sessions a week)
- Severe cachexia (loss of more than of 35% premorbid weight or weight loss more than 10% in the last 6 months).
- Morbidly obesity (BMI >40 kg/m2),
- Immunodepression (absolute neutrophils count < 500/mmc)
- Temporary
- Uncontrolled pain or new onset bone pain until further diagnostic study
- Severe anemia (haemoglobin below 8 g/dL) or platelet count lower than <50000/μL
- Fever (temperature above 38ºC) or acute infections
- Severe nausea and vomiting within previous 24-36 h
- Uncontrolled blood pressure (systolic blood pressure > 160 mm Hg and/or diastolic blood pressure >99 mm Hg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapted Physical Activity (APA), Insulin Resistance, Oxidative Stress and Microcirculatory Haemodynamics in Breast Cancer Patients.
The aim of this study is to investigate the effect of a 6-months program of Adapted Physical Activity (APA) on lifestyle, physical activity levels, insulin resistance and adipokines, oxidative stress, microcirculatory haemodynamics and serum levels of specific circulating miRNA in post-menopausal, physically inactive breast cancer patients in oncologic follow-up with or without hormone therapy that had completed adjuvant treatment (radiotherapy and/or chemotherapy) .
Furthermore, the study will determine the impact of APA on functional capabilities, on self-reported physical activity, quality of life and psychic health.
Read the detailed description
This is a randomized controlled double-group assignment study with intermedial switch-over including post-menopausal, physically inactive breast cancer patients in oncological follow-up with or without hormone therapy, that had completed adjuvant post-surgical treatment (radiotherapy and/or chemotherapy) from at least 3 months and from not more than 3 years.
Patients in hormonal therapy and patient not in hormonal therapy will be assigned in two different groups, each one of 50 patients. In each groups, patients will be randomized divided in a control group (25 pt) and in a 6 months-physical training group (25 pt). After 6-months patient in control group will be switched in the physical training group.
The duration of the study is 2 year. Clinical evaluation of the patients will be made: at the enrollment, after 6, 12, and 24 months.
Physical activity will be adapted according to arm and shoulder morbidity, after fracture risk assessment. Exercise will be concentrated solely on leg muscles (pedalling on a cycle or bed ergometer) in individuals with limitations in the range of motion of the arms (eg, due to breast, axillary, or thoracic surgery). In patients experiencing ataxia, dizziness, or peripheral neuropathy, walking outdoors and mostly cycle-ergometry training will be preferred to other activities that also involve large muscle groups but require additional balance and coordination (eg, treadmill walking, outdoor cycling).
Exercises will be performed at the Unipolar Spinal Unit of "S. Maria della Misericordia" Hospital, Perugia.
The aim of the study is to confirm the positive effect of APA on metabolic stress, body mass composition, functional capacity, serum levels of specific circulating miRNA and quality of life in breast cancer patients in oncological follow-up.
Currently, only few data are available about the relationship between physical activity and microcirculatory hemodynamics that, together with oxidative stress, could be involved in genesis and progression of breast cancer.
- Conditions
- Breast Neoplasms, Exercise, Exercise Therapy, Insulin Resistance, Oxidative Stress, Microcirculation
- Being tested
- Exercise
- Medical subject headings
- Breast Neoplasms, Motor Activity, Insulin Resistance, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The exercise intervention consists of 60 minutes sessions, divided into 40 minutes of aerobic exercise and 20 minutes of circuit training for muscular strength and flexibility exercises.
Aerobic exercise is performed using treadmill, exercise bikes, syncro and arm-ergometers, gradually increasing the exercise intensity, after a 10 minutes period of warming-up, to 60-80 % of Maximum Heart Rate.
Resistance training consists of resistance exercises for large muscle groups, performed with body weight-exercises and isotonic machines.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Patients involved in the 6 months-physical training group. Receives: Other: Exercise |
| Control | No intervention | Patients in control group carry on their usual follow-up programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity levels
Self reported physical activity, using IPAQ-SF (International Physical Activity Questionnairev - Short Form) score
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Change in BMI
Reduction of BMI expressed as body mass (kg) / height^2 (m^2)
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Secondary outcomes (10)
Change in Post-Occlusive Reactive Hyperemia (PORH)
Improvement of Area of Hyperemia (AH) at Post-Occlusive Reactive Hyperemia (PORH) on Laser Doppler velocimetry (Periflux System 5000, Perimed), expressed as Perfusion Units (PU).
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Carotid intima-media thickness (IMT)
Improvement of macrovascular structures, that will be explored by carotid intima-media thickness (IMT) (two-dimensional B-mode ultrasonography), measured in mm.
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Arterial stiffness
Reduction of arterial stiffness, that will be evaluated by radial applanation tonometry (SphygmoCor) and general transfer function assessing PWV (measure in m/s).
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Hemorheological profile
Improvement of Hemorheological profile, that will be studied with Serum, Plasma, and Blood Viscosity (Haake rotational viscometer), measured as mPas.
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Serum adiponectin
Improvement of serum adiponectin, measured by ELISA-method (ng/ml). Blood samples will be collected in the morning between 7:00 and 9:00 am, after overnight fasting.
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Serum IGF-1
Improvement of serum IGF-1, measured by ELISA-method (ng/ml). Blood samples will be collected in the morning between 7:00 and 9:00 am, after overnight fasting.
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
VFA (Visceral Fat Area)
Improvement of Ultrasound assesment of visceral fat area (VFA, by MyLab 50 Ultrasonography, Esaote), measured by Hirooka formula (cm^2)
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
HOMA-IR index
Homeostatic model assessment (HOMA) for insulin resistance (IR) is a method for assessing β-cell function and insuline resistance from basal (fasting) glucose and insulin or C-peptide concentrations. HOMA-IR can be calculated with a simple mathematical approximation as HOMA-IR = (FPI × FPG)/22.5, where FPI is fasting plasma insulin concentration (mU/l) and FPG is fasting plasma glucose (mmol/l), or as HOMA-IR = (FPI × FPG)/405 if fasting plasma glucose is expressed in mg/dl.
Values bethween 3 and 5 are considered expression of moderate insuline resistance; values upper 5 are considered expression of severe insuline resistance.
Improvement of insulin-sensitivity expressed as HOMA-IR index reduction.
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Maximal aerobic capacity (VO2max)
Increase of maximal aerobic capacity after physical training, measured as ml/kg/min.
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
miRNA
Variation of serum miR-10b, 15a, 146, 155, 375 e let-7a,b,c concentrations.
Measured: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, double-group assignment, open label study with intermediate crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ettore Marini, University Of Perugia
- Investigators
- Leonella Pasqualini, MD, Study director, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528473
- Sponsor's protocol ID
- APA-PG1
- Status last verified
- Sep 2021
- First submitted
- 22 Mar 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adraskela K, Veisaki E, Koutsilieris M, Philippou A. Physical Exercise Positively Influences Breast Cancer Evolution. Clin Breast Cancer. 2017 Oct;17(6):408-417. doi: 10.1016/j.clbc.2017.05.003. Epub 2017 May 19.
PubMed 28606800Foucaut AM, Berthouze-Aranda SE, Touillaud M, Kempf-Lepine AS, Baudinet C, Meyrand R, Carretier J, Bachmann P, Fervers B. Reduction of health risk factors through an adapted physical activity program in patients with breast cancer. Support Care Cancer. 2014 Apr;22(4):1097-104. doi: 10.1007/s00520-013-2065-3. Epub 2013 Dec 3.
PubMed 24292096Franses JW, Edelman ER. The evolution of endothelial regulatory paradigms in cancer biology and vascular repair. Cancer Res. 2011 Dec 15;71(24):7339-44. doi: 10.1158/0008-5472.CAN-11-1718. Epub 2011 Dec 5.
PubMed 22144472Ye J, Jia J, Dong S, Zhang C, Yu S, Li L, Mao C, Wang D, Chen J, Yuan G. Circulating adiponectin levels and the risk of breast cancer: a meta-analysis. Eur J Cancer Prev. 2014 May;23(3):158-65. doi: 10.1097/CEJ.0b013e328364f293.
PubMed 23929213Tesarova P, Kalousova M, Zima T, Suchanek M, Malikova I, Kvasnicka J, Duskova D, Tesar V, Vachek J, Krupickova-Kasalova Z, Malik J. Endotelial activation and flow-mediated vasodilation in young patients with breast cancer. Neoplasma. 2013;60(6):690-7. doi: 10.4149/neo_2013_088.
PubMed 23906304
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity (APA), Insulin Resistance, Oxidative Stress and Microcirculatory Haemodynamics in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT03528473
- Acronym / sponsor ID
- APA-PG1
- Conditions
- Breast Neoplasms, Exercise, Exercise Therapy, Insulin Resistance, Oxidative Stress, Microcirculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 May 2018 (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.
The aim of this study is to investigate the effect of a 6-months program of Adapted Physical Activity (APA) on lifestyle, physical activity levels, insulin resistance and adipokines, oxidative stress, microcirculatory haemodynamics and serum levels of specific circulating miRNA in post-menopausal, physically inactive breast cancer patients in oncologic follow-up with or without hormone therapy that had completed adjuvant treatment (radiotherapy and/or chemotherapy) .
Furthermore, the study will determine the impact of APA on functional capabilities, on self-reported physical activity, quality of life and psychic health.
Detailed description
This is a randomized controlled double-group assignment study with intermedial switch-over including post-menopausal, physically inactive breast cancer patients in oncological follow-up with or without hormone therapy, that had completed adjuvant post-surgical treatment (radiotherapy and/or chemotherapy) from at least 3 months and from not more than 3 years.
Patients in hormonal therapy and patient not in hormonal therapy will be assigned in two different groups, each one of 50 patients. In each groups, patients will be randomized divided in a control group (25 pt) and in a 6 months-physical training group (25 pt). After 6-months patient in control group will be switched in the physical training group.
The duration of the study is 2 year. Clinical evaluation of the patients will be made: at the enrollment, after 6, 12, and 24 months.
Physical activity will be adapted according to arm and shoulder morbidity, after fracture risk assessment. Exercise will be concentrated solely on leg muscles (pedalling on a cycle or bed ergometer) in individuals with limitations in the range of motion of the arms (eg, due to breast, axillary, or thoracic surgery). In patients experiencing ataxia, dizziness, or peripheral neuropathy, walking outdoors and mostly cycle-ergometry training will be preferred to other activities that also involve large muscle groups but require additional balance and coordination (eg, treadmill walking, outdoor cycling).
Exercises will be performed at the Unipolar Spinal Unit of "S. Maria della Misericordia" Hospital, Perugia.
The aim of the study is to confirm the positive effect of APA on metabolic stress, body mass composition, functional capacity, serum levels of specific circulating miRNA and quality of life in breast cancer patients in oncological follow-up.
Currently, only few data are available about the relationship between physical activity and microcirculatory hemodynamics that, together with oxidative stress, could be involved in genesis and progression of breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, double-group assignment, open label study with intermediate crossover
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExercisePatients involved in the 6 months-physical training group. |
| Control | No intervention | –Patients in control group carry on their usual follow-up programme. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- breast cancer patients in oncological follow-up
- post-menopausal age
- physically inactivity (light to moderate or vigorous leisure-time physical activity less than 10 minutes a day, US National Health Interview Survey)
- assuming or not hormone therapy
- after 3 months - 3 years from adjuvant post-surgical treatment (radiotherapy and/or chemotherapy)
Key exclusion criteria (17 listed)
- Permanent
- Patients older than 80 years
- Inability to carry on physical activity
- Metastatic neoplasia or unknown stage and/or histology
- Concomitant neoplasia
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 |
|---|---|---|
| ExerciseThe exercise intervention consists of 60 minutes sessions, divided into 40 minutes of aerobic exercise and 20 minutes of circuit training for muscular strength and flexibility exercises. Aerobic exercise is performed using treadmill, exercise bikes, syncro and arm-ergometers, gradually increasing the exercise intensity, after a 10 minutes period of warming-up, to 60-80 % of Maximum Heart Rate. Resistance training consists of resistance exercises for large muscle groups, performed with body weight-exercises and isotonic machines. | Other | Exercise |
Primary outcome
Change in physical activity levels
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Self reported physical activity, using IPAQ-SF (International Physical Activity Questionnairev - Short Form) score
Change in BMI
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Reduction of BMI expressed as body mass (kg) / height^2 (m^2)
10 secondary outcomes
Change in Post-Occlusive Reactive Hyperemia (PORH)
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Carotid intima-media thickness (IMT)
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Arterial stiffness
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Hemorheological profile
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Serum adiponectin
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Serum IGF-1
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
VFA (Visceral Fat Area)
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
HOMA-IR index
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Maximal aerobic capacity (VO2max)
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
miRNA
Time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 28606800Adraskela K, Veisaki E, Koutsilieris M, Philippou A. Physical Exercise Positively Influences Breast Cancer Evolution. Clin Breast Cancer. 2017 Oct;17(6):408-417. doi: 10.1016/j.clbc.2017.05.003. Epub 2017 May 19.
- Background: PubMed 24292096Foucaut AM, Berthouze-Aranda SE, Touillaud M, Kempf-Lepine AS, Baudinet C, Meyrand R, Carretier J, Bachmann P, Fervers B. Reduction of health risk factors through an adapted physical activity program in patients with breast cancer. Support Care Cancer. 2014 Apr;22(4):1097-104. doi: 10.1007/s00520-013-2065-3. Epub 2013 Dec 3.
- Background: PubMed 22144472Franses JW, Edelman ER. The evolution of endothelial regulatory paradigms in cancer biology and vascular repair. Cancer Res. 2011 Dec 15;71(24):7339-44. doi: 10.1158/0008-5472.CAN-11-1718. Epub 2011 Dec 5.
- Background: PubMed 23929213Ye J, Jia J, Dong S, Zhang C, Yu S, Li L, Mao C, Wang D, Chen J, Yuan G. Circulating adiponectin levels and the risk of breast cancer: a meta-analysis. Eur J Cancer Prev. 2014 May;23(3):158-65. doi: 10.1097/CEJ.0b013e328364f293.
- Background: PubMed 23906304Tesarova P, Kalousova M, Zima T, Suchanek M, Malikova I, Kvasnicka J, Duskova D, Tesar V, Vachek J, Krupickova-Kasalova Z, Malik J. Endotelial activation and flow-mediated vasodilation in young patients with breast cancer. Neoplasma. 2013;60(6):690-7. doi: 10.4149/neo_2013_088.
- Individual participant dataSharing planned: No
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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.
Leonella Pasqualini, MD study director
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Breast Neoplasms and Exercise, run by University Of Perugia 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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 5 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 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?
Results are not available in the source record.
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?
Change in physical activity levels (time frame: Evaluation baseline and after 6, 12 and 24 months from enrollment.). The study lists 2 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 NCT03528473, which also lists 5 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 5 Oct 2021.