Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT01322412
- Lead Sponsor
- University Hospital, Limoges
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme 27 weeks
- Secondary Outcome Measures
Name Time Method Assessment at 27 and 54 weeks between the 2 groups of muscle function. 54 weeks
Trial Locations
- Locations (1)
Limoges University Hospital
🇫🇷Limoges, France