Rationale and design of a randomized double-blind clinical trial in breast cancer: Dextromethorphan in chemotherapy-induced peripheral neuropathy
Rationale and design of a randomized double-blind clinical trial in breast cancer: Dextromethorphan in chemotherapy-induced peripheral neuropathy
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DOI：
10.1016/j.cct.2015.01.012
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发表时间：
2015-03-01
影响因子：
2.2
通讯作者：
Pickering, Gisele
中科院分区：
文献类型：
--
作者：
Martin, Elodie;Morel, Veronique;Pickering, Gisele
背景：抗癌化疗常诱发周围神经病变，并导致认知和生活质量受损。指南推荐使用抗癫痫药或抗抑郁药，但其疗效有限。右美沙芬是一种N-甲基-D-天冬氨酸受体拮抗剂，已显示其在疼痛性糖尿病神经病变和术后疼痛中的疗效，但尚未研究其在化疗引起的周围神经病变中的作用。本临床试验评估了美沙芬对乳腺癌化疗引起的神经性疼痛患者的疼痛、认知和生活质量的影响。它还评估了对alphaumethorphan基因多态性的影响alphaumethorphan基因多态性对alphaumethorphan基因多态性的影响alphaumethorphan基因多态性对alphaumethorphan基因多态性的影响alphaumethorphan基因多态性的影响alphaumethorphan基因多态性对alphaumethorphan基因多态性的影响alphaumethorphan基因多态性的影响alphaumethorphan基因多态性对alphaumethorphan基因多态性的影响alphaumethorphan基因多态性的影响alphaumethorphan基因多态性的影响alphaumethorphan基因多态性对alphaumethorphan基因多态性的影响alphaumethorphan基因多态性的影响alphaumethorphan基因多态性对alphaumethorphan基因多态性的影响alphaumethorphan基因多态性的影响alphaum它包括40名患有化疗引起的周围神经病变的乳腺癌患者。他们被随机分配到美沙芬（最大剂量90 mg/天）或安慰剂组，持续4周。主要终点是治疗4周后在（0 - 10）数字疼痛评定量表上测量的疼痛强度。次要结局包括神经性疼痛、认知功能、焦虑/抑郁、睡眠和生活质量的评估。使用混合模型进行数据分析，检验是双侧的，I型误差设定为α = 0.05。讨论：考虑到现有药物在化疗引起的神经性疼痛中的疗效较差，美沙芬可能是一种有价值的治疗选择。药物遗传学可提供乳腺癌患者对美沙芬反应的预测因素。(C)2015爱思唯尔公司All rights reserved.
Background: Anti-cancer chemotherapy often induces peripheral neuropathy and consequent cognitive and quality of life impairment. Guidelines recommend antiepileptics or antidepressants but their efficacy is limited.Dextromethorphan, a N-methyl-D-aspartate receptor antagonist, has shown its efficacy in painful diabetic neuropathy and in post-operative pain but has not been studied in chemotherapy-induced peripheral neuropathy. This clinical trial evaluates the effect of dextromethorphan on pain, cognition and quality of life in patients who suffer from neuropathic pain induced by chemotherapy for breast cancer. It also assesses the impact of dextromethorphan genetic polymorphism on analgesia.Methods and design: This trial is a randomized, placebo-controlled, double-blind clinical study in two parallel groups (NCT02271893). It includes 40 breast cancer patients suffering from chemotherapy-induced peripheral neuropathy. They are randomly allocated to dextromethorphan (maximal dose 90 mg/day) or placebo for 4 weeks. The primary endpoint is pain intensity measured after 4 weeks of treatment on a (0-10) Numeric Pain Rating Scale. Secondary outcomes include assessment of neuropathic pain, cognitive function, anxiety/depression, sleep and quality of life. Data analysis is performed using mixed models and the tests are two-sided, with a type I error set at alpha=0.05.Discussion: Considering the poor efficacy of available drugs in chemotherapy-induced neuropathic pain, dextromethorphan may be a valuable therapeutic option. Pharmacogenetics may provide predictive factors of dextromethorphan response in patients suffering from breast cancer. (C) 2015 Elsevier Inc. All rights reserved.