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Completed

NCT Number: NCT02934880

Impact of Adapted Physical Activity on Cognitive Functions in 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse, Caen, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immediate APA program

Other

10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized

delayed APA program

Other

10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized

Primary outcomes

  1. 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

  1. Improval of quality of life

    Time frame: After APA program

    Impact of APA on quality of life (FACT-B result)

  2. Comparison of immediate APA and delayed APA on quality of life

    Time frame: 30 months

    Comparison between FACT-B, FACT-COG and FACIT-F results in the two groups

  3. Study of relations between cognitive functions and quality pf life

    Time frame: After APA program

    Correlation between patient questionnaire and data of psychological tests done by neuropsychologist

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: COG-SPORTIF

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2016
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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