Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach: Interest Using the SUDOSCAN® Machine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Evaluation of neuropathy by electrophysiological methods using SUDOSCAN
研究概览
简要总结
Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer. However, the development of neuropathic pain under treatment limits its use. These are manifested by acute hyperesthesia / distal cold allodynia and chronic course of hypoesthesia.
It is widely reported that these pains are consecutive to hyperexcitability of some ioniques2 channels (mainly sodium and potassium channels). However, the pathophysiological mechanisms of neurotoxicity are multifactorial and still imperfectly described.
Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose challenge is to quantify / measure NAION and explained by a biochemical approach, specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study insofar design methodology relies heavily on techniques developed for LIPIDOXA study and that the expected results will be complementary to those of LIPIDOXA.
详细描述
Main objective:
it is, in cancer patients chronically treated with oxaliplatin (over 5 courses) and exhibiting signs of neuropathy, to correlate the quantitative changes in the thermal sensitivity to hot and cold (Thermotest, Quantitative Sensory Testing QST ) with any changes in the ion conductance chlorine measured by electrophysiological technique (SUDOSCAN).
Secondary objectives:
- Correlating the results obtained with both types of techniques and with the descriptive parameters of the population included.
- Understand the importance of regulating the activity of the chloride channel in the development of neuropathy induced by oxaliplatin.
Methodology :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient newly treated with oxaliplatin
- •Patient suffering from any type of cancer treated with oxaliplatin
- •Man or Woman over 18
排除标准
- •Patient with brain or leptomeningeal metastases
- •Patient previously treated with cisplatin
- •Patient addicted to alcohol
- •Diabetic patient with peripheral neurological disorders
- •Patient receiving calcium or magnesium salts intravenously
- •Patient suffering from peripheral neuropathy
- •Patient suffering from psychiatric disorders
- •Patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.
研究组 & 干预措施
All patients
Measure of painful neuropathy for al patients with thermotest and sudoscan Devices and Neuropathic Pain Symptom Inventory.
干预措施: Assessment of neuropathic pain with theThermotest device (Device)
All patients
Measure of painful neuropathy for al patients with thermotest and sudoscan Devices and Neuropathic Pain Symptom Inventory.
干预措施: Assessment of neuropathic pain with SUDOSCAN device (Device)
All patients
Measure of painful neuropathy for al patients with thermotest and sudoscan Devices and Neuropathic Pain Symptom Inventory.
干预措施: Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory. (Device)
结局指标
主要结局
Evaluation of neuropathy by electrophysiological methods using SUDOSCAN
时间窗: Day 1
The SUDOSCAN is a new technology fast and non-invasive to quantify the degree of neuropathy objectively through evaluation of chloride conductance of the skin on the palm of the hand and soles of the feet2). This can evaluate the neuropathy for quantitative measurement of neuropathic pain
次要结局
- Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain(Day 1)
- NPSI ange of Characterization of pain neuropathy(Day 1)