NCT02934880

Brief Summary

Breast cancer is the most frequent cancer in women in western countries. The improvement of therapeutic management associated to the developement of supportive care allows patient to live longer in better conditions. But several studies have showed the deleterious impact of treatment such as chemotherapy on cognition. To limit these damages, non therapeutic approaches such as Adapted Physical Activity (APA) have been developped. The goal of this study is to evaluate the benefit of APA program on cognitive functions in patients with locally advanced breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

October 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 19, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

October 14, 2016

Last Update Submit

December 29, 2025

Conditions

Breast Cancer

Keywords

adapted physical activity, cognitive functions

Outcome Measures

Primary Outcomes (1)

  • proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result

    Proportion of patient with an increase superior or equal to seven points between FACT-COG at the inclusion and FACT-COG after APA program

    After APA program

Secondary Outcomes (3)

  • Improval of quality of life

    After APA program

  • Comparison of immediate APA and delayed APA on quality of life

    30 months

  • Study of relations between cognitive functions and quality pf life

    After APA program

Study Arms (2)

Immediate APA

EXPERIMENTAL

intervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization

Other: immediate APA program

Delayed APA

ACTIVE COMPARATOR

intervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization

Other: delayed APA program

Interventions

delayed APA programOTHER

10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized

Delayed APA
immediate APA programOTHER

10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized

Immediate APA

Eligibility Criteria

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

You may qualify if:

  • Women
  • More than 18 years old
  • Locally advanced breast cancer
  • Patient who undergone surgery
  • Cognitive complaint (FACT-COG inferior or equal to 8/16)
  • Patient who received adjuvant therapy by chemotherapy
  • Patient with a social protection
  • Barbizet scale Superior or equal to 3
  • No neurological history
  • No medical contraindication to APA
  • Inform consent signed

You may not qualify if:

  • Metastatic breast cancer
  • Current chemotherapy or radiotherapy
  • Chemotherapy or radiotherapy ended for more than 6 months
  • Current APA program
  • Blood transfusion for less than 6 mois
  • Minimal mental score inferior to normal
  • Patient no able to respond to the cognitive test
  • Patient no able to realize APA program
  • Drug use
  • Alcohol abuse
  • Patient Under guardianship or curatorship or deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre François Baclesse

Caen, 14076, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Olivier Rigal, MD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 17, 2016

Study Start

January 19, 2017

Primary Completion

January 18, 2023

Study Completion

January 18, 2023

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)