Breast Cancer
Conditions
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.
Interventions
OTHERphysical activity
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test | at 12 months | unit of measure:ml/kg/min |
Secondary
| Measure | Time frame |
|---|---|
| Exercise tolerance at 12 months (group A vs B) | at 12 months |
Countries
France
Outcome results
None listed