Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: APAD

• Registration Number: NCT04109326
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.

Detailed Description

The experimental arm "APAD": tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment

The experimental program will include:

* 8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week.

* 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.

The control arm: standard of care

Study Timeline

• Study Start: 2013-05-15
• Primary Completion: 2016-01-05
• Study Completion: 2016-06-11
• Status Verified: 2019-09
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-27
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

• Female patient with histologically proven breast cancer
• Age ≥18 years old
• Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + 3 taxanes) followed by radiotherapy
• Satisfactory healing from surgical act on breast and lymph nodes
• 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

• Metastatic disease
• Any other primary tumor
• Contra-indication to moderate physical activity: Unchecked high blood pressure; family history of sudden death in a first degree relative; not stabilized heart disease; acute or chronic lung disease resulting in dyspnea for moderate effort; uncontrolled diabetes, carrying a stent; other severe pathologies unstabilized, disabled or not indicated to physical practice.
• Contra-indication to adjuvant chemotherapy or radiotherapy
• Pregnancy or breast feeding (according to the recommendations of the usual adjuvant breast cancer)
• Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
• Legal inability or restricted legal ability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapted Physical Activity and Dietetique	APAD	tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment

Primary Outcome Measures

Name	Time	Method
Rate of cancer-related fatigue	6 months	The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire.

Trial Locations

Locations (8)

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CH Ambroise Paré; 🇫🇷 Marseille, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Institut de Cancéologie de l'Ouest; 🇫🇷 Saint-Herblain, France

CH Montélimar; 🇫🇷 Montélimar, France

ICM; 🇫🇷 Montpellier, France