Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients (APAD2)

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 : Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: APAD

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 Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Marseille, France, 13003
    • CH Ambroise Paré
  • Montpellier, France, 34298
    • ICM
  • Montélimar, France, 26216
    • CH Montélimar
  • Rennes, France, 35042
    • Centre Eugene Marquis
  • Saint-Herblain, France, 44805
    • Institut de Cancéologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Experimental: Adapted Physical Activity and Dietetique; tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment	Other: APAD; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Study Chair: Gilles Romieu, Institut du Cancer de Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2013
• Primary Completion (Actual): January 5, 2016
• Study Completion (Actual): June 11, 2016

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer; Nutrition; Physical activity; Therapeutic education
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: VA2012/39; 2012-A01648-35 (Registry Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No