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 : Multicenter Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Enrollment
- 360
- Locations
- 8
- Primary Endpoint
- Rate of cancer-related fatigue
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of cancer-related fatigue
Time Frame: 6 months
The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire.