Clinical trial NCT02934880: Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer
Official title: Study of Impact of Adapted Physical Activity on Cognitive Functions and Quality of Life in Patients Treated for Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: adapted physical activity, cognitive functions
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result
timeFrame: After APA program
Secondary outcomes:
measure: Improval of quality of life
timeFrame: After APA program
measure: Comparison of immediate APA and delayed APA on quality of life
timeFrame: 30 months
measure: Study of relations between cognitive functions and quality pf life
timeFrame: After APA program
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: Centre Oscar Lambret
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Olivier Rigal, MD
role: PRINCIPAL_INVESTIGATOR
References: