Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy: a Randomized, Non-comparative, Placebo-controlled, Single-blinded, Phase II Clinical Trial in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) (including taxanes, platinum, al pervenche from Madagascar alkaloids...), is a frequent secondary effect of treatments: 68% at 1-month post-chemotherapy, 60% at 3 months and 30% after 6 months. Symptoms associated with CIPN are usually symmetric and bilateral (typical distribution in "gloves and socks") inducing sensory alterations, paresthesias, dysesthesias, numbness and pain. Neuropathic Pain (NP) is an important characteristic of CIPN, affects 25-80% of patients with CIPN, and reduces quality of life (e.g., concomitant psychological distress, risks of falls, risks of neurocognitive impairments, and sleep disorders).
In severe cases, it is even necessary to delay and/or reduce the dose of chemotherapy. The benefit of drug interventions on NP remains limited. To date, there are no proven preventive strategies and few evidence-based treatment options for CIPN. Also, the use of complementary or non-pharmacological interventions are common, including photobiomodulation (PBM).
PBM is the therapeutic use of non-ionizing laser light for its anti-inflammatory and regenerative effects. Its use is currently recommended only for the prevention of oral mucositis related to cancer treatments. Recent preliminary clinical evidence suggests that PBM may be beneficial to established CIPN, with safety and improvement beyond the intervention. However, to date, clinical trials are rare, have methodological weaknesses, and/or focus on global CIPN. The overall objectives of the study are therefore to assess the effectiveness, feasibility and safety of the PBM for treating NP in the CIPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years minimum;
- •Patient with cancer, whatever the location;
- •Patient with significant NP defined as a score of 4 at the clinician-rated DN4 ;
- •Patient with a NP for at least 3 months after the end of an adjuvant or neo-adjuvant chemotherapy;
- •Women of childbearing potential must have a pregnancy urinary test within a maximum of 7 days before starting the study treatment. A negative result must be documented before study treatment is started. Women without reproductive potential are postmenopausal women or women who have undergone permanent sterilisation (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy);
- •Effective contraception for women of childbearing age
- •Patient having signed informed consent prior to any study procedure;
- •Patient affiliated to a French social protection system;
- •Patient sufficiently fluent in French to complete questionnaires, as the investigator clinical discretion.
排除标准
- •Patient unable to come twice a week to the investigator center;
- •Patient unable to sit for a 30-minutes period;
- •Patient with an open wound or ulcer on the treatment area;
- •Patient whose diagnosis of peripheral neuropathy is due to another cause (n.b., diabetes without neuropathy will not be a specific exclusion);
- •Patient with uncontrolled psychiatric illness or neurocognitive impairment that may interfere with assessments, as the investigator clinical discretion;
- •Patient whose estimated life expectancy is less than 3 months, as estimated by a clinical investigator;
- •Patient using another concurrent non-pharmacological intervention or complementary therapy for neuropathy during the study;
- •Patient who has been treated with CAPSAISINE during the previous 3 months;
- •Patient with pacemaker;
- •Epileptic patient;
- •Patient with photosensitive medications, or any medical condition causing sensitivity to light (n.b., Lupus);
- •Pregnant and/or breastfeeding woman;
- •Patient with primary tumor and/or metastases in areas to be treated by BPM (i.e., hands and/or feet);
- •Patient with pre-existing eye disease (such as maculopathy, glaucoma, cataract and retinal lesions), or a history of family eye diseases;
- •Patient who has been already been treated with photobiomodulation on the area of interest.
- •Participation in another concomitant clinical study with neuropathic pain or chemo-induced peripheral neuropathy as the primary endpoint.
- •Presence of a tattoo on the area to be treated.
研究组 & 干预措施
Control arm
In the sham therapy, patients will have the same procedure as the laser intervention (i.e., visit schedule, eye mask, equipment, and application body regions), but without joules.
Patients in this placebo arm will have the opportunity to receive the real treatment at the end of the study if they wish.
Experimental arm
Photobiomodulation sessions (2 per week for 4 weeks, 8 sessions in total) will be delivered by certified laser safety clinicians (i.e., algologists, pain nurses or neuropsychologists).
The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm. The light will be applied to all hands and/or feet for 13 minutes. The order of transfer between feet and hands will be counterbalanced so that, half of the sessions will have started with feet, and the other half will have started with hands. The dose will be specified at each session.
Patients will be treated in a sitting position (to treat the hands) or a semi-seated position (for feet). They will wear opaque glasses to ensure the safety of the laser and the blind condition of treatment
干预措施: Photobiomodulation sessions (Device)
结局指标
主要结局
Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group
时间窗: from the baseline to 12 weeks after the treatment
the proportion of responders to a photobiomodulation intervention on their neuropathic pain at 12 weeks
次要结局
- Description of the evolution of neurocognitive executive functioning(from the baseline to 6 months after the treatment)
- Assessment of the photobiomodulation adherence(from the baseline to 4 weeks after the beginning of the treatment)
- Evaluation of the safety of the photobiomodulation(from the baseline to 6 months after the treatment)
- Description of the evolution of neuropathic pain(from the baseline to 6 months after the treatment)
- Exploration of the evolution of global pain measures(from the baseline to 6 months after the treatment)
- Description of the evolution of the Chemotherapy-induced peripheral neuropathy(from the baseline to 6 months after the treatment)
- Exploration of the evolution of quality of life(from the baseline to 6 months after the treatment)
- Exploration of the evolution of sleep disorders(from the baseline to 6 months after the treatment)
- Assessment of emotional distress(from the baseline to 4 weeks, 8 weeks and 12 weeks after the treatment)
- Description of the evolution of neurocognitive executive functioning(from the baseline to 6 months after the treatment)
- Description of the evolution of neuropathic pain(from the baseline to 6 months after the treatment)
- Exploration of the evolution of global pain measures(from the baseline to 6 months after the treatment)
- Exploration of the evolution of quality of life(from the baseline to 6 months after the treatment)
- Description of the evolution of the Chemotherapy-induced peripheral neuropathy(from the baseline to 6 months after the treatment)
- Exploration of the evolution of sleep disorders(from the baseline to 6 months after the treatment)
- Assessment of the photobiomodulation adherence(from the baseline to 4 weeks after the beginning of the treatment)
- Evaluation of the safety of the photobiomodulation(from the baseline to 6 months after the treatment)