Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer

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. 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
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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 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.

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

Conditions
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Breast Cancer

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 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. Exclusion Criteria: 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 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A : physical activity program<br>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<br>Arm B : conventional management during and after treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme |  | 27 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment at 27 and 54 weeks between the 2 groups of muscle function. |  | 54 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adapted physical activity, breast cancer