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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
APAD
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Physical activity, Nutrition, Therapeutic education, Breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Sainte Catherine
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • CH Ambroise Paré
  • ICM
  • CH Montélimar
  • Centre Eugène Marquis
  • Institut de Cancéologie de l'Ouest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adapted Physical Activity and Dietetique

Control

Arm Description

tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment

Standard of care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2019
Last Updated
September 27, 2019
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT04109326
Brief Title
Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients
Acronym
APAD2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2013 (Actual)
Primary Completion Date
January 5, 2016 (Actual)
Study Completion Date
June 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Physical activity, Nutrition, Therapeutic education, Breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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 control arm: standard of care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapted Physical Activity and Dietetique
Arm Type
Experimental
Arm Description
tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Other
Intervention Name(s)
APAD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of cancer-related fatigue
Description
The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Romieu
Organizational Affiliation
Institut du Cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CH Ambroise Paré
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
ICM
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CH Montélimar
City
Montélimar
ZIP/Postal Code
26216
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Institut de Cancéologie de l'Ouest
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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