Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase

Study Overview
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Brief Summary
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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 or néoadjuvant chemotherapy.

Official Title
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Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 for whom a 6-treatment course of adjuvant or neoadjuvant chemotherapy (3FEC100 +3 taxanes or 6 FEC) +/- radiotherapy+/- Herceptin has been scheduled; Exclusion Criteria: metastatic cancer; disability preventing a proper understanding of the instructions for the trial; patients who are subject to a court protection, wardship or guardianship order; uncontrolled hypertension; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A<br>6-month ETP, during adjuvant or neoadjuvant therapy | Other: physical activity<br> <br> |
| Other: Arm B<br>6-month ETP, after adjuvant or neoadjuvant therapy | Other: physical activity<br> <br> |
| Other: Arm C<br>12-monthETP, during and after adjuvant or neoadjuvant treatment | Other: physical activity<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test | unit of measure:ml/kg/min | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise tolerance at 12 months (group A vs B) |  | at 12 months |