Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer

Centre Henri Becquerel37 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

immediate APA programOTHER

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

delayed APA programOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Centre François Baclesse

Caen, France

Centre Oscar Lambret

Lille, France

Centre Henri Becquerel

Rouen, France

Outcomes

Primary Outcomes

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

Time frame: After APA program

Secondary Outcomes

Improval of quality of life

Impact of APA on quality of life (FACT-B result)

Time frame: 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

Time frame: 30 months

Study of relations between cognitive functions and quality pf life

Correlation between patient questionnaire and data of psychological tests done by neuropsychologist

Time frame: After APA program

Data from ClinicalTrials.gov

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