Clinical Trial

Breast Cancer and Chemobrain : Effects of Photobiomodulation on the Improvement of Perceived Cognitive Impairment

Study acronym: REGAIN
Recruiting
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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 occurring in women under 50. Treatment is mainly based on surgery, chemotherapy, radiotherapy, targeted therapies and hormone therapy. Although chemotherapy is not systematically used, it remains a frequent treatment option. While chemotherapy makes a major contribution to curing cancer, it is also a source of potentially disabling side effects for survivors. Chemotherapy can interfere with the normal functioning of the central nervous system, leading to cognitive impairment. The number of people potentially affected by chemobrain is estimated at several tens of millions worldwide. There is no recommended treatment for people with chemobrain. Several avenues have been explored, with very limited results. Photobiomodulation (PBM) is a non-medicinal treatment technique that combines all the biological, athermic and non-cytotoxic effects of tissue exposure to non-ionizing sources of red and infrared light. Several studies have demonstrated the beneficial effects of cortical stimulation by photobiomodulation on memory (increased angiogenesis, increased oxygenation of brain tissue via vasodilatation, and increased mitochondrial ATP production). These positive biological effects are likely to ameliorate the undesirable effects of chemotherapy, and consequently the post-chemotherapy cognitive disorders that ensue.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-26.
Status change: Not Yet Recruiting → Recruiting 2026-01-29
Trial Details
NCT Number NCT06995443
Lead Sponsor Centre Hospitalier de Valenciennes
Conditions Oncology, Support Care, Cognitive Disorders
Enrollment 200 participants
Start Date 2025-06-13
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-30