An interventional study of Photobiomodulation in Oncology, Support Care and Cognitive Disorders, sponsored by Centre Hospitalier de Valenciennes. Recruiting at 1 site in France. Open to female participants. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Centre Hospitalier de Valenciennes · Not applicable, Interventional, and Other
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Centre Hospitalier de Valenciennes is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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
Other: Photobiomodulation
12 sessions of photobiomodulation (1 per week) Visit 1 to 4 : photobiomodulation (NOVOTHOR) + cortical stimulation (VEILIGHT) Visit 5 to 12 : cortical stimulation (VEILIGHT)
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)
Time frame: From enrollment to the end of follow-up visit at 13 weeks (V13 = V12 + 7d +/- 3d)
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
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)
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
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)
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"
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)
Perceived health on a Likert scale by answering the question "How would you rate your health: very good, good, bad, very bad"
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
Overall FACT-Cog score at S13 and 6-month follow-up
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
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)?
Time frame: At the follow-up visit V13 (=V12 + 7d +/- 3d)
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Centre Hospitalier de Valenciennes