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

Centre Henri Becquerel

Status: Completed

Conditions: Breast Cancer

Treatments: Other: immediate APA program; Other: delayed APA program

Study type: Interventional

Funder types: Other

Identifiers

NCT02934880

CHB16.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

37 participants in 2 patient groups

Immediate APA

Experimental group

Description:

intervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization

Treatment:

Other: immediate APA program

Delayed APA

Active Comparator group

Description:

intervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization

Treatment:

Other: delayed APA program