Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment

Study 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.

Official Title
-----------------
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.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Tailored program of PA and nutritional counseling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br> | Behavioral: Tailored program of PA and nutritional counseling<br>* Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).<br>|
| No Intervention: Control arm<br>Routine practice | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective fatigue | Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire | At 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life is measured by the EORTC QLC-C30 questionnaire | At 18 months | 
| Anxiety/depressive symptoms | Anxiety/depressive symptoms is measured by the HADS questionnaire | At 18 months | 
| Physical activity level | Physical activity level is measured by the GPAQ questionnaire | At 18 months | 
| Muscular fatigue | Muscular fatigue is measured by Myotest | At 18 months | 
| Attention fatigue | Attention fatigue is measured usingt the TAP 2.2 software | At 18 months | 
| Body Mass Index | Body Mass Index is calculated using bodyweight and length measurements | At 18 months | 
| Body composition | Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA) | At 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comprehensive Adjuvant Care, Cancer-related fatigue, Therapeutic patient education, Physical Activity, Nutritional counselling, Rehabilitation