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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
immediate APA program
delayed APA program
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring adapted physical activity, cognitive functions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre François Baclesse
  • Centre Oscar Lambret
  • Centre Henri BecquerelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate APA

Delayed APA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improval of quality of life
Impact of APA on quality of life (FACT-B result)
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
Study of relations between cognitive functions and quality pf life
Correlation between patient questionnaire and data of psychological tests done by neuropsychologist

Full Information

First Posted
October 14, 2016
Last Updated
July 10, 2018
Sponsor
Centre Henri Becquerel
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1. Study Identification

Unique Protocol Identification Number
NCT02934880
Brief Title
Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
adapted physical activity, cognitive functions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate APA
Arm Type
Experimental
Arm Description
intervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization
Arm Title
Delayed APA
Arm Type
Active Comparator
Arm Description
intervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization
Intervention Type
Other
Intervention Name(s)
immediate APA program
Intervention Description
10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized
Intervention Type
Other
Intervention Name(s)
delayed APA program
Intervention Description
10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized
Primary Outcome Measure Information:
Title
proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result
Description
Proportion of patient with an increase superior or equal to seven points between FACT-COG at the inclusion and FACT-COG after APA program
Time Frame
After APA program
Secondary Outcome Measure Information:
Title
Improval of quality of life
Description
Impact of APA on quality of life (FACT-B result)
Time Frame
After APA program
Title
Comparison of immediate APA and delayed APA on quality of life
Description
Comparison between FACT-B, FACT-COG and FACIT-F results in the two groups
Time Frame
30 months
Title
Study of relations between cognitive functions and quality pf life
Description
Correlation between patient questionnaire and data of psychological tests done by neuropsychologist
Time Frame
After APA program

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Rigal, MD
Phone
+33276672241
Email
olivier.rigal@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Rigal, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne Delcambre, Md
Email
c.delcambre@baclesse.unicancer.fr
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Vanlemmens, MD
Email
l-vanlemmens@o-lambret.fr
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Rigal, Md
Phone
+33276672241
Email
olivier.rigal@chb.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer

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