Background:Chemotherapy-induced peripheral neuropathy (CIPN) from oxaliplatin and taxane drugs is a bothersome toxicity. Palmitoylethanolamide (PEA) has been reported to improve myelinated nerve fiber function in patients experiencing painful CIPN. We conducted a double-blind, placebo-controlled, randomized trial of PEA in patients with established CIPN.Methods:Eligible patients were adults who had pain, numbness, tingling, or other symptoms of CIPN for at least three months following completion of paclitaxel, oxaliplatin, or cisplatin-based chemotherapy. Study patients were randomized to one of the two treatment groups (PEA versus placebo, both administered either once or twice daily). The CIPN20 questionnaire was assessed weekly.Results:A total of 17 males and 71 females participated in the study; most had neuropathy from paclitaxel. Most (85%) finished 8 weeks of treatment. There was no suggestion that either of the PEA arms did any better than the combined placebo arms. There was no signal of significant toxicity differences between the three study arms. Quality of life outcome measures were similar between the study arms, as were cognitive function evaluations.Discussion:PEA failed to improve established CIPN. Future trials might explore whether PEA may be effective in preventing CIPN or cognitive changes based on data that suggest it may be helpful in this situation.Conclusions:PEA failed to improve established chemotherapy-induced neuropathy.
背景：由奥沙利铂和紫杉烷类药物引起的化疗诱导性周围神经病变（CIPN）是一种令人困扰的毒性反应。据报道，棕榈酰乙醇酰胺（PEA）可改善患有疼痛性CIPN患者的髓鞘神经纤维功能。我们针对已确诊的CIPN患者进行了一项PEA的双盲、安慰剂对照、随机试验。 方法：符合条件的患者为成年人，在完成基于紫杉醇、奥沙利铂或顺铂的化疗后，出现疼痛、麻木、刺痛或其他CIPN症状至少三个月。研究患者被随机分配到两个治疗组之一（PEA组与安慰剂组，均每日一次或两次给药）。每周评估CIPN20问卷。 结果：共有17名男性和71名女性参与了本研究；大多数患者因紫杉醇引起神经病变。大多数（85%）完成了8周的治疗。没有迹象表明PEA组的任一剂量方案比合并的安慰剂组表现更好。三个研究组之间未发现显著的毒性差异。生活质量结果指标在各研究组之间相似，认知功能评估结果也相似。 讨论：PEA未能改善已确诊的CIPN。基于表明PEA可能在此情况下有帮助的数据，未来的试验可能会探讨PEA是否在预防CIPN或认知变化方面有效。 结论：PEA未能改善已确诊的化疗诱导性神经病变。
肿瘤(癌症)患者之家