D'Andre Stacy, Novotny Paul, Walters Camille, Lewis-Peters Susie, Thomé Stephan, Tofthagen Cindy S, Giridhar Karthik V, Loprinzi Charles
Department of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Department of Statistics, Mayo Clinic, Rochester, Minnesota, USA.
Cannabis Cannabinoid Res. 2024 Dec;9(6):e1556-e1564. doi: 10.1089/can.2023.0253. Epub 2024 Jul 17.
Patients have been known to use cannabinoids for treating established chemotherapy-induced peripheral neuropathy (CIPN) based on anecdotal information and retrospective reports suggesting that such might be beneficial. In response, a double-blinded, placebo-controlled, randomized, pilot clinical trial was developed to evaluate whether resultant data would support a phase III trial for testing whether a cannabidiol (CBD) cream might improve CIPN. Forty patients with established CIPN were randomized, in a double-blinded manner, to topical CBD or a placebo cream. The study product was applied for 2 weeks, followed by a crossover for 2 weeks. Neuropathy was evaluated using the European Organization of Research and Treatment of Cancer (EORTC)-CIPN20, the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool, and the Global Impression of Change instruments. Side effects were recorded by symptom diaries. The EORTC-CIPN20 scores were similar in the patients receiving CBD versus the placebo. Likewise, the toxicity scores were similar in patients who received the CBD versus the placebo. This pilot trial did not support that the studied CBD isolate cream improved painful established CIPN. It was well tolerated overall. NCT05388058.
基于轶事信息和回顾性报告表明大麻素可能有益，已知患者会使用大麻素治疗已确诊的化疗引起的周围神经病变（CIPN）。作为回应，开展了一项双盲、安慰剂对照、随机的试点临床试验，以评估所得数据是否支持进行III期试验，测试大麻二酚（CBD）乳膏是否可改善CIPN。40名已确诊CIPN的患者以双盲方式随机分配至外用CBD或安慰剂乳膏组。研究产品应用2周，随后交叉使用2周。使用欧洲癌症研究与治疗组织（EORTC）-CIPN20、化疗引起的周围神经病变评估工具和总体变化印象工具评估神经病变。通过症状日记记录副作用。接受CBD与安慰剂的患者的EORTC-CIPN20评分相似。同样，接受CBD与安慰剂的患者的毒性评分也相似。这项试点试验不支持所研究的CBD分离乳膏可改善已确诊的疼痛性CIPN。总体耐受性良好。NCT05388058。
