Breast CancerSAPANCT01322412
Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer
An observational study of Breast Cancer, run by University Hospital, Limoges at 1 site in France.
Trial summary
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Jul 2013
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: adjuvant breast cancer
Who may be able to join
- females between 18 and 75 years of age
- signed written informed consent
- willing to take part in the trial and to follow the instructions
- breast tumour, histologically documented
- patients who have undergone curative surgery
- patients for whom a 6-treatment course of adjuvant chemotherapy (3FEC100 + taxanes) and radiotherapy has been scheduled
- patients with HER2-negative cancer.
Who cannot join
- metastatic cancer
- other primary tumours
- disability preventing a proper understanding of the instructions for the trial
- chemotherapy strictly contra-indicated
- patients who are subject to a court protection, wardship or guardianship order
- uncontrolled hypertension
Show all 15Show fewer
- family history of sudden death in a first-degree relative
- unstabilised heart disease
- current treatment with beta-blockers
- chronic or acute pulmonary disease associated with dyspnoea upon moderate effort
- uncontrolled thyroid dysfunction
- uncontrolled diabetes
- any other serious conditions that are unstabilised, disabling or in which physical exercise is contra-indicated
- unable to attend for follow-up throughout the duration of the study
- ventricular ejection fraction (vef) < 50%, pregnancy or suckling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation.
Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.
Read the detailed description
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.
A total of 44 subjects is required. The programme is organised as follows: Arm A (aerobic and strength training) and during the 27 weeks of treatment (chemotherapy and radiotherapy); Arm B (control group). This study includes 3 assessments phases (T0: before adjuvant chemotherapy; T1 (week 27) and T2: final evaluation at the 54th week). These assessments include: cardiopulmonary exercise test including maximal oxygen uptake test (VO2max), six-minute walk test, muscular testing, assessment of physical activity (IPAQ questionnaire), fatigue (MFI20 questionnaire), quality of life (EORTC QLQ C30), anxiety and depression symptoms (HADS) and nutritional evaluation: BMI and total body photonic absorption.
- Conditions
- Breast Cancer
- Keywords
- Adapted physical activity, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : physical activity program | Arm A : physical activity program (aerobic and strength training) during the 27 weeks of treatment (chemotherapy and radiotherapy) and conventional follow-up during 27 weeks | |
| Arm B : conventional management | Arm B : conventional management during and after treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme
Measured: 27 weeks
Secondary outcomes (1)
Assessment at 27 and 54 weeks between the 2 groups of muscle function.
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent FRANCOIS, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322412
- Sponsor's protocol ID
- I10 009 / SAPA
- Acronym
- SAPA
- Status last verified
- Mar 2011
- First submitted
- 23 Mar 2011
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cornette T, Vincent F, Mandigout S, Antonini MT, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N. Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized controlled trial. Eur J Phys Rehabil Med. 2016 Apr;52(2):223-32. Epub 2015 May 19.
PubMed 25986222
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase
- ClinicalTrials.gov ID
- NCT01322412
- Acronym / sponsor ID
- SAPA / I10 009 / SAPA
- Conditions
- Breast Cancer
- Keywords
- Adapted physical activity, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Mar 2011 (estimated)
- 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.
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation.
Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.
Detailed description
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.
A total of 44 subjects is required. The programme is organised as follows: Arm A (aerobic and strength training) and during the 27 weeks of treatment (chemotherapy and radiotherapy); Arm B (control group). This study includes 3 assessments phases (T0: before adjuvant chemotherapy; T1 (week 27) and T2: final evaluation at the 54th week). These assessments include: cardiopulmonary exercise test including maximal oxygen uptake test (VO2max), six-minute walk test, muscular testing, assessment of physical activity (IPAQ questionnaire), fatigue (MFI20 questionnaire), quality of life (EORTC QLQ C30), anxiety and depression symptoms (HADS) and nutritional evaluation: BMI and total body photonic absorption.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : physical activity program | – | –Arm A : physical activity program (aerobic and strength training) during the 27 weeks of treatment (chemotherapy and radiotherapy) and conventional follow-up during 27 weeks |
| Arm B : conventional management | – | –Arm B : conventional management during and after treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adjuvant breast cancer
Key inclusion criteria (7 listed)
- females between 18 and 75 years of age
- signed written informed consent
- willing to take part in the trial and to follow the instructions
- breast tumour, histologically documented
- patients who have undergone curative surgery
Key exclusion criteria (15 listed)
- metastatic cancer
- other primary tumours
- disability preventing a proper understanding of the instructions for the trial
- chemotherapy strictly contra-indicated
- patients who are subject to a court protection, wardship or guardianship order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme
Time frame: 27 weeks
1 secondary outcome
Assessment at 27 and 54 weeks between the 2 groups of muscle function.
Time frame: 54 weeks
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 21 Aug 2018.
- Results publication: PubMed 25986222Cornette T, Vincent F, Mandigout S, Antonini MT, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N. Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized controlled trial. Eur J Phys Rehabil Med. 2016 Apr;52(2):223-32. Epub 2015 May 19.
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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.
Vincent FRANCOIS, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Hospital, Limoges at 1 site in France.
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 15 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 21 Aug 2018. 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 France. 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?
main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme (time frame: 27 weeks). 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 NCT01322412, which also lists 1 linked publication.
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 21 Aug 2018.