Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer

NCT ID: NCT02934880

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-19

Study Completion Date

2023-01-18

Brief Summary

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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.

Detailed Description

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Patient with cognitive complaint will be randomized in two groups :

* Experimental group : Immediate APA program (after randomization)
* Standard group : Delayed APA program (3 months after randomization)

APA program contains 10 sessions of APA within five weeks (twice a week). Each session is composed of 5 exercises (each made of 3 serial of 7 repetitions in slow speed).

A cognitive and quality of life assessments will occur in two groups at 3 and 6 months after randomization.

The primary objective of the study is to evaluate the impact of APA program on the improvement of cognitive functions in patients with breast cancer who have been treated by adjuvant chemotherapy.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Immediate APA

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

Group Type EXPERIMENTAL

immediate APA program

Intervention Type OTHER

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

Delayed APA

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

Group Type ACTIVE_COMPARATOR

delayed APA program

Intervention Type OTHER

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

Interventions

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immediate APA program

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

Intervention Type OTHER

delayed APA program

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women
* More than 18 years old
* Locally advanced breast cancer
* Patient who undergone surgery
* Cognitive complaint (FACT-COG inferior or equal to 8/16)
* No metastasis at the inclusion
* 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

Exclusion Criteria

* Metastatic breast cancer
* History of other cancer (in 5 years before inclusion)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Rigal, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

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Centre François Baclesse

Caen, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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CHB16.01

Identifier Type: -

Identifier Source: org_study_id

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