Study of Impact of Adapted Physical Activity on Cognitive Functions and Quality of Life in Patients Treated for Locally Advanced Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Centre Henri Becquerel
- Enrollment
- 37
- Locations
- 3
- Primary Endpoint
- proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
- •Alcohol abuse
- •Patient Under guardianship or curatorship or deprived of liberty
Arms & Interventions
Immediate APA
intervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization
Intervention: immediate APA program (Other)
Delayed APA
intervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization
Intervention: delayed APA program (Other)
Outcomes
Primary Outcomes
proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result
Time Frame: After APA program
Proportion of patient with an increase superior or equal to seven points between FACT-COG at the inclusion and FACT-COG after APA program
Secondary Outcomes
- Comparison of immediate APA and delayed APA on quality of life(30 months)
- Improval of quality of life(After APA program)
- Study of relations between cognitive functions and quality pf life(After APA program)