Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University Hospital, Limoges
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test
- 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. 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.
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 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;
Outcomes
Primary Outcomes
The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test
Time Frame: at 12 months
unit of measure:ml/kg/min
Secondary Outcomes
- Exercise tolerance at 12 months (group A vs B)(at 12 months)