OncologyREGAINNCT06995443
Breast Cancer and Chemobrain : Effects of Photobiomodulation on the Improvement of Perceived Cognitive Impairment
A study testing Photobiomodulation in people with Oncology and Support Care, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Oncology, Support Care, Cognitive Disorders
- What is being tested?
- Photobiomodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Valenciennes
Valenciennes, 59300
About this study
Official title: Breast Cancer and Chemobrain : Effects of Photobiomodulation on the Improvement of Perceived Cognitive Impairment - REGAIN
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.
- Conditions
- Oncology, Support Care, Cognitive Disorders
- Being tested
- Photobiomodulation
- Keywords
- Cognitive disorders, Photobiomodulation, Breast cancer, oncology
- Medical subject headings
- Neoplasms, Cognitive Dysfunction, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationOther
12 sessions of photobiomodulation (1 per week) Visit 1 to 4 : photobiomodulation (NOVOTHOR) + cortical stimulation (VEILIGHT) Visit 5 to 12 : cortical stimulation (VEILIGHT)
| Study group | Role | What they receive |
|---|---|---|
| Usual care with photobiomodulation sessions | Experimental | Photobiomodulation : 1 session per week during 12 weeks Visit 1 to Visit 4 : Photobiomodulation (NOVOTHOR) + cortical stimulation (VEILIGHT) Visit 5 to 12 : Cortical stimulation Visit 13 (V12 + 7 days +/- 3 days) : FACT-COG / anxiety measure / depression measure / Likert scale / satisfaction Visit 6 months (V1 + 6M +/- 2 weeks) : questionnary FACT-COG Receives: Other: Photobiomodulation |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Patients with an evolution subjective cognitive performance between the FACT-Cog performed at inclusion and that at the end of follow-up (S13)
Measured: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)
Secondary outcomes (6)
Compare the rate of patients considered anxious in each group at inclusion (T0) and at the end of the follow-up period (S13)
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
Measured: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)
To compare the rate of patients considered depressed in each group at inclusion (T0) and at the end of the follow-up period (S13)
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
Measured: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)
Compare perceived sleep quality in each group at inclusion (T0) and at the end of the follow-up period (13)
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"
Measured: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)
Compare perceived health in each group at inclusion (T0) and at the end of the follow-up period (S13)
Perceived health on a Likert scale by answering the question "How would you rate your health: very good, good, bad, very bad"
Measured: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)
Describe in the experimental group only the evolution of the FACT-Cog score at the end of photobiomodulation treatment (S13) and at 6 months
Overall FACT-Cog score at S13 and 6-month follow-up
Measured: From follow-up visit at 13 weeks and 6 months after the first session of photobiomodulation (V1 + 6M +/-2W)
Evaluate the level of satisfaction of patients in the intervention group regarding the course of PBM sessions
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)?
Measured: At the follow-up visit V13 (=V12 + 7d +/- 3d)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start13 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995443
- Sponsor's protocol ID
- 2024-02-02
- Acronym
- REGAIN
- Status last verified
- Jan 2026
- First submitted
- 26 Feb 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer and Chemobrain : Effects of Photobiomodulation on the Improvement of Perceived Cognitive Impairment - REGAIN
- ClinicalTrials.gov ID
- NCT06995443
- Acronym / sponsor ID
- REGAIN / 2024-02-02
- Conditions
- Oncology, Support Care, Cognitive Disorders
- Keywords
- Cognitive disorders, Photobiomodulation, Breast cancer, oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care with photobiomodulation sessions | Experimental | Other: PhotobiomodulationPhotobiomodulation : 1 session per week during 12 weeks Visit 1 to Visit 4 : Photobiomodulation (NOVOTHOR) + cortical stimulation (VEILIGHT) Visit 5 to 12 : Cortical stimulation Visit 13 (V12 + 7 days +/- 3 days) : FACT-COG / anxiety measure / depression measure / Likert scale / satisfaction Visit 6 months (V1 + 6M +/- 2 weeks) : questionnary FACT-COG |
| Usual care | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation12 sessions of photobiomodulation (1 per week) Visit 1 to 4 : photobiomodulation (NOVOTHOR) + cortical stimulation (VEILIGHT) Visit 5 to 12 : cortical stimulation (VEILIGHT) | Other | Usual care with photobiomodulation sessions |
Primary outcome
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)
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Oncology and Support Care, run by Centre Hospitalier de Valenciennes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lidvine GODAERT, MD (03.27.14.91.19, godaert-l@ch-valenciennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.