Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach
关键词
抽象
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 :
Prospective study, single center, intervention in routine care. Time study: February 2015 - October 2016
1. Evaluation of neuropathy by electrophysiological methods (SUDOSCAN) The SUDOSCAN is a new technology fast and non-invasive to quantify the degree of neuropathy objectively through evaluation of chloride conductance at the skin of the palms and the soles of pieds4,5.
2. Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain
The pain symptoms was evaluated through various semi-objective neuropathy quantification tools (Quantitative Sensory Testing devices) 6:
- The Thermotest (Somedic®): medical device that measures the thermal sensitivity thresholds to cold and hot: cold sensitivity threshold, threshold of sensitivity to hot, cold pain threshold, pain threshold warm. These stimuli are transmitted by the fiber Adelta and C. Since dysesthesia to thermal stimuli (allodynia in acute and chronical hypoesthesia) are typical of oxaliplatin, Thermotest is fundamental.
- Questionnaire NPSI (Neuropathic Pain Symptom Inventory) widely used in the field and validated.
3. Statistical Analysis: Professor Gilles Chatellier, statistician (Clinical Research Unit, Hôpital Européen Georges Pompidou) will bring its expertise in statistical analysis.
NB: For each subject will be awarded an identifier (simple counter: increment as and measurement of inclusions) and the data will be entered on a computer file which will be sent to the statistician in charge of the analysis. There will be no exchange of personal data for this study is single center on the site GHPSJ.
Development of the study:
- Inclusion of patients treated with oxaliplatin from 6th cycle (FOLFOX protocols FOLFIRINOX, EOX, GEMOX, EOF, XELOX).
- Expected duration of patient recruitment: 9 months
- Number of patients to recruit and duration of participation for each patient: Based on 75 patients seen in 9 months in GHSPJ the oncology department for cancer of the digestive tract, and knowing that the prevalence of neuropathic pain in oxaliplatin is 50-70% (Attal 2009), the investigators plan to include at least 36 patients in this period of 9 months.
日期
最后验证: | 08/31/2017 |
首次提交: | 06/28/2016 |
提交的预估入学人数: | 07/07/2016 |
首次发布: | 07/10/2016 |
上次提交的更新: | 09/03/2017 |
最近更新发布: | 09/05/2017 |
实际学习开始日期: | 04/03/2016 |
预计主要完成日期: | 04/12/2016 |
预计完成日期: | 06/29/2017 |
状况或疾病
干预/治疗
Device: All patients
Device: All patients
Device: All patients
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: All patients Measure of painful neuropathy for al patients with thermotest and sudoscan Devices and Neuropathic Pain Symptom Inventory. | Device: All patients Measure of painful neuropathy with thermotest |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Patient newly treated with oxaliplatin - Patient suffering from any type of cancer treated with oxaliplatin - Man or Woman over 18 Exclusion Criteria: - 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. |
结果
主要结果指标
1. Evaluation of neuropathy by electrophysiological methods using SUDOSCAN [Day 1]
次要成果指标
1. Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain [Day 1]
2. NPSI ange of Characterization of pain neuropathy [Day 1]