A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Subjective fatigue
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.
Detailed Description
Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female patient with histologically proven breast cancer
- •18-76 years old
- •Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + taxanes) followed by radiotherapy
- •Satisfactory healing of breast and lymph nodes area
- •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
- •HER2 positive or metastatic cancer
- •Any other primary tumor
- •Contraindication to moderate physical activity
- •Contraindication to adjuvant chemotherapy or radiotherapy
- •Pregnancy or breast feeding
- •Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial
Outcomes
Primary Outcomes
Subjective fatigue
Time Frame: At 18 months
Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire
Secondary Outcomes
- Physical activity level(At 18 months)
- Anxiety/depressive symptoms(At 18 months)
- Attention fatigue(At 18 months)
- Body Mass Index(At 18 months)
- Quality of life(At 18 months)
- Muscular fatigue(At 18 months)
- Body composition(At 18 months)