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NCT Number: NCT06995443

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

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.

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Key information

Conditions

Oncology Breast Diseases Breast Neoplasms Cognition Disorders Cognitive Disorders Cognitive Dysfunction Mental Disorders Neoplasms Neoplasms by Site Neurocognitive Disorders Skin Diseases Skin and Connective Tissue Diseases Support Care

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation

Other

12 sessions of photobiomodulation (1 per week) Visit 1 to 4 : photobiomodulation (NOVOTHOR) + cortical stimulation (VEILIGHT) Visit 5 to 12 : cortical stimulation (VEILIGHT)

Primary outcomes

  1. To compare, among women aged 18 and over who had undergone chemotherapy for breast cancer and had subjective cognitive impairment post-chemotherapy, the rate of those showing improvement in cognitive impairment with or without photobiomodulation (cortica

    Time frame: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

    Patients with an evolution subjective cognitive performance between the FACT-Cog performed at inclusion and that at the end of follow-up (S13)

Secondary outcomes

  1. Compare the rate of patients considered anxious in each group at inclusion (T0) and at the end of the follow-up period (S13)

    Time frame: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

    For patients aged 18 to 65: HAD anxiety score (first 7 questions, score variable from 0 to 21).

    For patients > 65 years: GAI FC SF score (5 questions, score variable from 0 to 5).

    The cut-off will be 8 for the HAH anxiety score and 3 for the GAI FC SF

  2. To compare the rate of patients considered depressed in each group at inclusion (T0) and at the end of the follow-up period (S13)

    Time frame: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

    For patients aged 18 to 65: HAD depression score (last 7 questions, score variable from 0 to 21).

    For patients > 65 years: mini-GDS score (5 questions, score variable from 0 to 5).

    The cut-off will be 8 for the HAD anxiety score and 1 for the GAI FC SF

  3. Compare perceived sleep quality in each group at inclusion (T0) and at the end of the follow-up period (13)

    Time frame: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

    Perceived sleep on a Likert scale by answering the question "How would you rate the quality of your sleep: very good, good, bad, very bad"

  4. Compare perceived health in each group at inclusion (T0) and at the end of the follow-up period (S13)

    Time frame: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)

    Perceived health on a Likert scale by answering the question "How would you rate your health: very good, good, bad, very bad"

  5. Describe in the experimental group only the evolution of the FACT-Cog score at the end of photobiomodulation treatment (S13) and at 6 months

    Time frame: From follow-up visit at 13 weeks and 6 months after the first session of photobiomodulation (V1 + 6M +/-2W)

    Overall FACT-Cog score at S13 and 6-month follow-up

  6. Evaluate the level of satisfaction of patients in the intervention group regarding the course of PBM sessions

    Time frame: At the follow-up visit V13 (=V12 + 7d +/- 3d)

    Level of satisfaction with various aspects of the sessions on a Likert scale by answering the following questions:

    • Concerning the frequency of photobiomodulation sessions: "How would you rate your satisfaction on a scale from 0 (not satisfied at all) to 10 (completely satisfied)?
    • Concerning duration: "How would you rate your satisfaction on a scale from 0 (not satisfied at all) to 10 (completely satisfied)?
    • Concerning the organization of photobiomodulation sessions: "How would you rate your satisfaction on a scale from 0 (not satisfied at all) to 10 (completely satisfied)?

Study contacts

Contact information is provided by the study sponsor or research team.

Lidvine GODAERT, MD

CONTACT

[email protected]

03.27.14.91.19

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valenciennes

Network

Registry information

Official study title

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

Acronym: REGAIN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 29, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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