Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation
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
- Neuropathic Pain Synptom Inventory : pain
研究概览
简要总结
Peripheral neuropathy is one of the most common side effects of oxaliplatin (OXA)-based chemotherapy for patients treated for digestive cancers, disabling and dose-limiting. Several strategies have been studied for the treatment of oxaliplatin-related sensory neuropathy. Several pharmacological and non-pharmacological therapeutic strategies have been explored to relieve peripheral neuropathic pain. Non-pharmacological interventions have been shown to be potentially beneficial for patients suffering from chemotherapy-induced neurotoxicity. The objective of this prospective study is to evaluate the effectiveness of photobiomodulation on the reduction of neuropathic pain in patients who developed painful, cumulative peripheral neuropathy that appeared under the effect of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Recent diagnosis of digestive cancer
- •12 planned cycles of oxaliplatin
- •Ability to understand and willingness to sign an informed consent form before starting any study procedures
- •Patient benefiting from French health insurance
排除标准
- •History of neuropathy before the start of the study,
- •Symptomatic treatment of pain (or neuropathic pain),
- •Patient with a psychotic disorder,
- •Patient with diabetic neuropathy,
- •Patient with metastatic cancer
- •Patient with renal insufficiency,
- •Adults under guardianship or curatorship,
- •Vulnerable people
结局指标
主要结局
Neuropathic Pain Synptom Inventory : pain
时间窗: day 30, day 60, day 90, day 120, day 150, day 180, day 270
Is is a score with 12 items. 10 items concern pain and are scale from 0 (no pain) to 10 (maximal pain).
次要结局
- Peripheral neuropathy : electroneuromyogram evaluation(day 0, day 90, day 270)
- Health-relative quality of life of cancer patients participating to a clinical trial(day 0, day 60, day 120, day 180, day 270)
- Peripheral neuropathy : SUDOSCAN evaluation(day 0, day 30, day 60, day 90, day 120, day 150, day 180, day 270)
- Evaluation of sensitive and motor symptoms(day 30, day 60, day 90, day 120, day 150, day 180, day 270)