Photobiomodulation for thinking and memory problems after breast cancer chemotherapy
Breast Cancer and Chemobrain : Effects of Photobiomodulation on the Improvement of Perceived Cognitive Impairment - REGAIN
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | Female |
| Sponsor | Centre Hospitalier de Valenciennes Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Valenciennes) |
| Trial ID | NCT06995443 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Photobiomodulation has been examined in small or pilot studies for cognitive symptoms but evidence is limited and larger trials are needed to confirm benefit.
Eligibility criteria
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 this trial is running
Valenciennes
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.