Status:
NOT_YET_RECRUITING
Breast Cancer and Chemobrain : Effects of Photobiomodulation on the Improvement of Perceived Cognitive Impairment
Lead Sponsor:
Centre Hospitalier de Valenciennes
Conditions:
Oncology
Support Care
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Breast cancer is one of the most common cancers in metropolitan France, with over 60,000 new cases in 2023. Mostly a female cancer, it can affect a young population, with around 20% of breast cancers ...
Eligibility Criteria
Inclusion
- Women aged 18 and over
- Having completed chemotherapy (intravenous) for breast cancer (any stage) less than 12 months prior to inclusion
- Having a perceived cognitive complaint that appeared during or after (\< 3 months) chemotherapy treatments (no restriction on the care protocol used) and confirmed by a FACT-Cog score compatible with a subjective cognitive disorder (score \< 117 for patients aged 18 to 49; score \< 113 for patients aged 50 to 69; score \<105 for patients aged 70 and over)
- Patient eligible for photobiomodulation sessions
- Patient with sufficient command of the French language to complete the study questionnaries
- Patient having given written consent to participate in the trial
- Socially insured patient
- Patient willing to comply with all study procedures and duration
Exclusion
- Known cognitive disorders prior to chemotherapy treatment
- Patients with psychiatric or psychobehavioral disorders incompatible with photobiomodulation sessions
- Patients who, in the 12 months prior to inclusion or at the time of inclusion, have already received photobiomodulation treatment involving "whole body" therapy (photobiomodulation in a phototherapy booth).
- Patient having previously received photobiomodulation with cortical stimulation (panel or helmet) with no time limit.
- Patient taking or having received capecitabine
- Patients taking part in a protocol involving a drug likely to affect cognitive performance (on the investigator's advice).
- Patients suffering from claustrophobia
- Patient unable to read and/or unable to complete a questionnaire, in the opinion of the investigator
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06995443
Start Date
June 1 2025
End Date
December 1 2027
Last Update
May 29 2025
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