Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer
NCT ID: NCT02934880
Last Updated: 2026-01-02
Study Results
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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COMPLETED
NA
37 participants
INTERVENTIONAL
2017-01-19
2023-01-18
Brief Summary
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The goal of this study is to evaluate the benefit of APA program on cognitive functions in patients with locally advanced breast cancer.
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Detailed Description
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* 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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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
immediate APA program
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
delayed APA program
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
delayed APA program
10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Centre Henri Becquerel
OTHER
Responsible Party
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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
Centre Oscar Lambret
Lille, , France
Centre Henri Becquerel
Rouen, , France
Countries
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Other Identifiers
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CHB16.01
Identifier Type: -
Identifier Source: org_study_id
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