Breast Cancer
Conditions
Keywords
Comprehensive Adjuvant Care, Cancer-related fatigue, Therapeutic patient education, Physical Activity, Nutritional counselling, Rehabilitation
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.
Interventions
BEHAVIORALTailored program of PA and nutritional counseling
Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 76 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective fatigue | At 18 months | Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety/depressive symptoms | At 18 months | Anxiety/depressive symptoms is measured by the HADS questionnaire |
| Physical activity level | At 18 months | Physical activity level is measured by the GPAQ questionnaire |
| Muscular fatigue | At 18 months | Muscular fatigue is measured by Myotest |
| Quality of life | At 18 months | Quality of life is measured by the EORTC QLC-C30 questionnaire |
| Body Mass Index | At 18 months | Body Mass Index is calculated using bodyweight and length measurements |
| Body composition | At 18 months | Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA) |
| Attention fatigue | At 18 months | Attention fatigue is measured usingt the TAP 2.2 software |
Countries
France
Outcome results
None listed