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

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.

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Tailored program of PA and nutritional counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • CRLC Val d'Aurelle-Paul Lamarque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm	Behavioral: Tailored 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).
No Intervention: Control arm; 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

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Publications and helpful links

General Publications

• Carayol M, Ninot G, Senesse P, Bleuse JP, Gourgou S, Sancho-Garnier H, Sari C, Romieu I, Romieu G, Jacot W. Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial. BMC Cancer. 2019 Jul 25;19(1):737. doi: 10.1186/s12885-019-5896-6.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (Estimate): December 20, 2011

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical Activity; Cancer-related fatigue; Therapeutic patient education; Nutritional counselling; Comprehensive Adjuvant Care
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Fatigue
• Other Study ID Numbers: APAD; 2010-A00906-33 (Registry Identifier: ID-RCB)