Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer

Study Overview
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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.

Official Title
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Study of Impact of Adapted Physical Activity on Cognitive Functions and Quality of Life in Patients Treated for Locally Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: immediate APA program
* Other: delayed APA program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate APA<br>intervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization | Other: immediate APA program<br>* 10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized<br>|
| Active Comparator: Delayed APA<br>intervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization | Other: delayed APA program<br>* 10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improval of quality of life | Impact of APA on quality of life (FACT-B result) | After APA program | 
| Comparison of immediate APA and delayed APA on quality of life | Comparison between FACT-B, FACT-COG and FACIT-F results in the two groups | 30 months | 
| Study of relations between cognitive functions and quality pf life | Correlation between patient questionnaire and data of psychological tests done by neuropsychologist | After APA program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adapted physical activity, cognitive functions