Breast Cancer
Conditions
Keywords
Physical activity, Nutrition, Therapeutic education, Breast cancer
Brief summary
This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.
Detailed description
The experimental arm APAD: tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment The experimental program will include: * 8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week. * 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment. The control arm: standard of care
Interventions
OTHERAPAD
8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week. 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
* The experimental arm APAD: tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment * The control arm: standard of care
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patient with histologically proven breast cancer * Age ≥18 years old * Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + 3 taxanes) followed by radiotherapy * Satisfactory healing from surgical act on breast and lymph nodes * Ability to understand the nature, goal and study methodology * Consent to cooperate for clinical assessments * Affiliation to a social security regime or beneficiary of equivalent social protection * Written informed consent provided before any study specific procedures
Exclusion criteria
* Metastatic disease * Any other primary tumor * Contra-indication to moderate physical activity: Unchecked high blood pressure; family history of sudden death in a first degree relative; not stabilized heart disease; acute or chronic lung disease resulting in dyspnea for moderate effort; uncontrolled diabetes, carrying a stent; other severe pathologies unstabilized, disabled or not indicated to physical practice. * Contra-indication to adjuvant chemotherapy or radiotherapy * Pregnancy or breast feeding (according to the recommendations of the usual adjuvant breast cancer) * Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions * Legal inability or restricted legal ability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of cancer-related fatigue | 6 months | The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire. |
Countries
France
Outcome results
None listed