NCT04109326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2013

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.6 years

First QC Date

September 27, 2019

Last Update Submit

September 27, 2019

Conditions

Breast Cancer

Keywords

Physical activityNutritionTherapeutic educationBreast cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Adapted Physical Activity and Dietetique

EXPERIMENTAL

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

Other: APAD

Control

NO INTERVENTION

Standard of care

Interventions

APADOTHER

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.

Adapted Physical Activity and Dietetique

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Institut Sainte Catherine

Avignon, 84918, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

CH Ambroise Paré

Marseille, 13003, France

Location

CH Montélimar

Montélimar, 26216, France

Location

ICM

Montpellier, 34298, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Institut de Cancéologie de l'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

3-acetylpyridine adenine dinucleotide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Gilles Romieu

    Institut du Cancer de Montpellier - Val d'Aurelle

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: * 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2019

First Posted

September 30, 2019

Study Start

May 15, 2013

Primary Completion

January 5, 2016

Study Completion

June 11, 2016

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

FR(8)