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

September 27, 2019 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

Intervention / 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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Gilles Romieu, Institut du Cancer de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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