Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Tailored program of PA and nutritional counseling
- Registration Number
- NCT01495650
- Lead Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Tailored program of PA and nutritional counseling -
- Primary Outcome Measures
Name Time Method Subjective fatigue At 18 months Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire
- Secondary Outcome Measures
Name Time Method Physical activity level At 18 months Physical activity level is measured by the GPAQ questionnaire
Anxiety/depressive symptoms At 18 months Anxiety/depressive symptoms is measured by the HADS questionnaire
Attention fatigue At 18 months Attention fatigue is measured usingt the TAP 2.2 software
Body Mass Index At 18 months Body Mass Index is calculated using bodyweight and length measurements
Quality of life At 18 months Quality of life is measured by the EORTC QLC-C30 questionnaire
Muscular fatigue At 18 months Muscular fatigue is measured by Myotest
Body composition At 18 months Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)
Trial Locations
- Locations (1)
CRLC Val d'Aurelle-Paul Lamarque
🇫🇷Montpellier, France