Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University Hospital, Limoges
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme
Time Frame: 27 weeks
Secondary Outcomes
- Assessment at 27 and 54 weeks between the 2 groups of muscle function.(54 weeks)