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

Institut du Cancer de Montpellier - Val d'Aurelle240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

240

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 76 Years

Medical Language ↔ Plain English

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

Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire

Time frame: At 18 months

Secondary Outcomes

Quality of life

Quality of life is measured by the EORTC QLC-C30 questionnaire

Time frame: At 18 months

Anxiety/depressive symptoms

Anxiety/depressive symptoms is measured by the HADS questionnaire

Time frame: At 18 months

Physical activity level

Physical activity level is measured by the GPAQ questionnaire

Time frame: At 18 months

Muscular fatigue

Muscular fatigue is measured by Myotest

Time frame: At 18 months

Attention fatigue

Attention fatigue is measured usingt the TAP 2.2 software

Time frame: At 18 months

Body Mass Index

Body Mass Index is calculated using bodyweight and length measurements

Time frame: At 18 months

Body composition

Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)

Time frame: At 18 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes