LIPIDOXA, a Pilot Study of Analysis of Chronic Neuropathic Pain Markers in Patients Treated With Oxaliplatin-based Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Thermal thresholds
研究概览
简要总结
The role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy has been previously described in mice and in neuronal cell cultures (Massicot 2013); clinical manifestations and pathophysiological mechanisms potentially involved have also been described in humans (Andreas 2007) (Attal 2009).
The investigators team plans to conduct a translational clinicobiological research to explain the nature of the biochemical and molecular mechanisms of the development of oxaliplatin-induced painful neuropathy. To perform this project, the investigators propose to realize a pilot study in patients newly treated with oxaliplatin. This will be conducted in the oncology department of Paris Saint Joseph Hospital from May 2014 until the inclusion of 20 patients.
The main objective of this pilot study is to evaluate the occurrence of acute and chronic neuropathic pain occurring in patients newly treated with oxaliplatin. The characterization of this pain is based on validated tests (Cruccu 2010).
Moreover, the biochemical changes related to oxidative stress and those related to cellular lipid composition are characterized in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Patient newly traeted 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.
结局指标
主要结局
Thermal thresholds
时间窗: Three to six months
Four thermal thresholds are assessed by a Thermotest (Somedic AB): * cold perception threshold * warm perception threshold * cold pain threshold * warm pain threshold
次要结局
- Tactile sensitivity(Three to six months)