Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer

Breast Cancer Clinical Trial

— COG-SPORTIF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02934880
• Other study ID #: CHB16.01
• Status: Recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: April 2019

Study information

• Verified date: November 2017
• Source: Centre Henri Becquerel
• Contact: Olivier Rigal, MD
• Phone: +33276672241
• Email: olivier.rigal[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: April 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• immediate APA program
10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized
• delayed APA program
10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Centre Oscar Lambret	Lille
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improval of quality of life	Impact of APA on quality of life (FACT-B result)	After APA program
Secondary	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
Secondary	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