Breast CancerCOG-SPORTIFNCT02934880
Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer
A study testing immediate APA program and delayed APA program in people with Breast Cancer, run by Centre Henri Becquerel at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- immediate APA program and delayed APA program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Jan 2017to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
3 sites in 1 country.
France3 sites
Centre François Baclesse
Caen, 14076
Centre Oscar Lambret
Lille, 59000
Centre Henri Becquerel
Rouen, 76038
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- immediate APA program, delayed APA program
- Keywords
- adapted physical activity, cognitive functions
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate APA programOther
10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized
delayed APA programOther
10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized
| Study group | Role | What they receive |
|---|---|---|
| Immediate APA | Experimental | intervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization Receives: Other: immediate APA program |
| Delayed APA | Active comparator | intervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization Receives: Other: delayed APA program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After APA program
Secondary outcomes (3)
Improval of quality of life
Impact of APA on quality of life (FACT-B result)
Measured: 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
Measured: 30 months
Study of relations between cognitive functions and quality pf life
Correlation between patient questionnaire and data of psychological tests done by neuropsychologist
Measured: After APA program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start19 Jan 2017
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Rigal, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934880
- Sponsor's protocol ID
- CHB16.01
- Acronym
- COG-SPORTIF
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2016
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Impact of Adapted Physical Activity on Cognitive Functions and Quality of Life in Patients Treated for Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT02934880
- Acronym / sponsor ID
- COG-SPORTIF / CHB16.01
- Conditions
- Breast Cancer
- Keywords
- adapted physical activity, cognitive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate APA | Experimental | Other: immediate APA programintervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization |
| Delayed APA | Active comparator | Other: delayed APA programintervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women
- More than 18 years old
- Locally advanced breast cancer
- Patient who undergone surgery
- Cognitive complaint (FACT-COG inferior or equal to 8/16)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immediate APA program10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized | Other | Immediate APA |
| delayed APA program10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized | Other | Delayed APA |
Primary outcome
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
3 secondary outcomes
Improval of quality of life
Time frame: After APA program
Comparison of immediate APA and delayed APA on quality of life
Time frame: 30 months
Study of relations between cognitive functions and quality pf life
Time frame: After APA program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Rigal, MD principal investigator
Centre Henri Becquerel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate APA program and delayed APA program in people with Breast Cancer, run by Centre Henri Becquerel at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result (time frame: After APA program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.