Breast Cancer and Chemobrain : Effects of Photobiomodulation on the Improvement of Perceived Cognitive Impairment - REGAIN
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual care with photobiomodulation sessions
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
干预措施: Photobiomodulation (Other)
Usual care
结局指标
主要结局
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
时间窗: 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)
次要结局
- Compare the rate of patients considered anxious in each group at inclusion (T0) and at the end of the follow-up period (S13)(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)(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)(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)(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(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(At the follow-up visit V13 (=V12 + 7d +/- 3d))