Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer (COG-SPORTIF)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: immediate APA program; Other: delayed APA program

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Rouen, France, 76038
    • Centre Henri Becquerel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Olivier Rigal, MD, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2017
• Primary Completion (Actual): January 18, 2023
• Study Completion (Actual): January 18, 2023

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimated): October 17, 2016

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: adapted physical activity, cognitive functions
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CHB16.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No