Photobiomodulation for thinking and memory problems after breast cancer chemotherapy
Official title: Breast Cancer and Chemobrain : Effects of Photobiomodulation on the Improvement of Perceived Cognitive Impairment - REGAIN
Run by Centre Hospitalier de Valenciennes · NCT06995443 · Data updated 2026-11-12
This trial will try photobiomodulation (a non-drug light therapy) to see if it helps thinking and memory problems in women who finished chemotherapy for breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Centre Hospitalier de Valenciennes Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Valenciennes) |
| Status | Recruiting |
| Started | June 13, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT06995443 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who completed intravenous chemotherapy within the last 12 months, report new or worsening cognitive complaints confirmed by FACT-Cog scores, speak French, and can attend photobiomodulation sessions are ideal candidates.
✕Probably not a fit
Patients with cognitive disorders present before chemotherapy, those with psychiatric or behavioral conditions that prevent photobiomodulation, or those without measurable chemo-related complaints are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult women who developed perceived cognitive problems during or shortly after intravenous chemotherapy for breast cancer will receive photobiomodulation sessions. Eligibility is determined using FACT-Cog score thresholds and other clinical criteria, and participants must have completed chemotherapy within the past 12 months. The intervention is a non-invasive light therapy delivered in clinic with standardized baseline and follow-up assessments of self-reported cognitive function. Outcomes focus on changes in perceived cognitive impairment and the feasibility of delivering this non‑medicinal treatment.
Why it matters
Potential benefit: If successful, the treatment could reduce chemo-related thinking and memory complaints and improve daily functioning for breast cancer survivors.
How similar studies have gone: Photobiomodulation has been examined in small or pilot studies for cognitive symptoms but evidence is limited and larger trials are needed to confirm benefit.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Centre Hospitalier de Valenciennes
Valenciennes, France Recruiting
Study contacts
- Study coordinator: Lidvine GODAERT, MD
- Email: godaert-l@ch-valenciennes.fr
- Phone: 03.27.14.91.19
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.