Randomized Clinical Investigation of Photobiomodulation (PBM) for the Management of Early Peripheral Neuropathy Related to Medical Oncologic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- severity of CIPN measured by modified Total Neurpathy Score m-TNS
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. Photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients. PBM uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. Additionally, research demonstrated that the use of PBM for three weeks in a curative setting reduces the CIPN symptoms, which is associated with a better QoL. According to the updated WALT 2022 recommendations it is most optimal for neuropathy patients to receive twelve PBM sessions. The aim of this project is to evaluate the role of PBM administered to patients with " de novo " early signs of Peripheral neuropathy (PN) that are supposed to be related to ongoing anti-cancer therapy.
详细描述
Chemotherapy-induced peripheral neuropathy (PN) is a common side-effect of many anti-neoplastic agents; its prevalence is estimated to 20-50% but varies considerably according to many factors and might actually be underreported. PN is increasingly reported as a complication of cancer immunotherapy and various targeted therapies currently used for the treatment of cancer.
PN typically causes disabling, sensitive (paresthesia, dysesthesia, allodynia, loss of sensation), but can also cause motor dysfunction (muscle weakness, fatigue) and autonomic dysfunction (digestive disorders, orthostatic hypotension); once established, regression of symptoms is slow. The pathobiology of chemotherapy-induced PN is mainly unknown despite the documented involvement of neuroinflammatory, mitochondrial, and vascular mechanisms.
PN often compromises quality of life and is a frequent reason for dose reduction, treatment delay, or premature discontinuation of anticancer therapy.
So far, no standard therapy has been recommended, with the possible exception of duloxetine, which has been associated with a modest symptom improvement in cisplatin-treated patients.
In this context, innovative, non-pharmacological, and well-tolerated strategies are needed. Photobiomodulation (PBM), also known as low-level laser therapy (LLLT), uses specific wavelengths (red or near-infrared) to modulate cellular activity, promote nerve regeneration, reduce inflammation, and regulate pain. Already included in international recommendations for the management of oral mucositis induced by chemotherapy or radiotherapy, PBM is emerging as a potentially effective alternative for other cancer-related toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •All the patients admitted for medical oncological therapy to the day care facility (Hôpital de Jour) are eligible for the protocol.
- •Age 18 years or above
- •Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
- •Be able to understand the ICF and study-related questionnaires
- •Signed informed consent
排除标准
- •severe or unstable cardio-respiratory or musculoskeletal disease
- •Peripheral neuropathy previous to chemotherapy
- •Receiving potentially neurotoxic therapies other than given for cancer treatment
- •Interruption of more than two consecutive laser treatments
结局指标
主要结局
severity of CIPN measured by modified Total Neurpathy Score m-TNS
时间窗: At baseline (week 0) and at week 3 and week 6
Include several simple neurological tests
次要结局
- Pain & satisfaction by Numeric Rating Scale (0-10)(At baseline (Week0), and Week 3 and Week 6)
- Mobility by 6min walking test(At baseline (Week0), and Week 3 and Week 6)
- Quality of life by FACT-GOG-NTX questionnair(At baseline (Week0), and Week 3 and Week 6)