Topical Cannabidiol for Established Chemotherapy-Induced Neuropathy: A Pilot Randomized Placebo-Controlled Trial

被引:4
作者
D'Andre, Stacy [1 ]
Novotny, Paul [2 ]
Walters, Camille [3 ]
Lewis-Peters, Susie [4 ]
Thome, Stephan [1 ]
Tofthagen, Cindy S. [5 ]
Giridhar, Karthik V. [1 ]
Loprinzi, Charles [1 ]
机构
[1] Mayo Clin, Dept Med Oncol, 200 First St SW, Rochester, MN 55905 USA
[2] Mayo Clin, Dept Stat, Rochester, MN USA
[3] Mayo Clin, Dept Pharm, Rochester, MN USA
[4] Mayo Clin, Dept Nursing, Rochester, MN USA
[5] Mayo Clin, Dept Nursing, Jacksonville, FL USA
关键词
chemotherapy-induced neuropathy; cannabidiol; topical; clinical trial; INDUCED PERIPHERAL NEUROPATHY; PAIN; PERMEATION; MANAGEMENT; EFFICACY; DISEASE; TARGETS; SYSTEM; RELIEF;
D O I
10.1089/can.2023.0253
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Background: 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.Methods: 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.Results: 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.Conclusions: This pilot trial did not support that the studied CBD isolate cream improved painful established CIPN. It was well tolerated overall.Clinical Trial Registration Number: NCT05388058
引用
收藏
页码:e1556 / e1564
页数:9
相关论文
共 48 条
[1]   Cannabis in painful HIV-associated sensory neuropathy - A randomized placebo-controlled trial [J].
Abrams, D. I. ;
Jay, C. A. ;
Shade, S. B. ;
Vizoso, H. ;
Reda, H. ;
Press, S. ;
Kelly, M. E. ;
Rowbotham, M. C. ;
Petersen, K. L. .
NEUROLOGY, 2007, 68 (07) :515-521
[2]   Rational treatment of chemotherapy-induced peripheral neuropathy with capsaicin 8% patch: from pain relief towards disease modification [J].
Anand, Praveen ;
Elsafa, Enas ;
Privitera, Rosario ;
Naidoo, Kalnisha ;
Yiangou, Yiangos ;
Donatien, Philippe ;
Gabra, Hani ;
Wasan, Harpreet ;
Kenny, Laura ;
Rahemtulla, Amin ;
Misra, Peter .
JOURNAL OF PAIN RESEARCH, 2019, 12 :2039-2052
[3]  
[Anonymous], Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
[4]   Cannabinoids: Current and Future Options to Treat Chronic and Chemotherapy-Induced Neuropathic Pain [J].
Blanton, Henry L. ;
Brelsfoard, Jennifer ;
DeTurk, Nathan ;
Pruitt, Kevin ;
Narasimhan, Madhusudhanan ;
Morgan, Daniel J. ;
Guindon, Josee .
DRUGS, 2019, 79 (09) :969-995
[5]   Cannabidiol as an emergent therapeutic strategy for lessening the impact of inflammation on oxidative stress [J].
Booz, George W. .
FREE RADICAL BIOLOGY AND MEDICINE, 2011, 51 (05) :1054-1061
[6]   Pharmacological evidence of medicinal cannabis in oncology: a systematic review [J].
Brown, Danielle ;
Watson, Michael ;
Schloss, Janet .
SUPPORTIVE CARE IN CANCER, 2019, 27 (09) :3195-3207
[7]  
Busner Joan, 2007, Psychiatry (Edgmont), V4, P28
[8]   TRP Channel Cannabinoid Receptors in Skin Sensation, Homeostasis, and Inflammation [J].
Caterina, Michael J. .
ACS CHEMICAL NEUROSCIENCE, 2014, 5 (11) :1107-1116
[9]   The non-psychoactive cannabis constituent cannabidiol is an orally effective therapeutic agent in rat chronic inflammatory and neuropathic pain [J].
Costa, Barbara ;
Trovato, Anna Elisa ;
Comelli, Francesca ;
Giagnoni, Gabriella ;
Colleoni, Mariapia .
EUROPEAN JOURNAL OF PHARMACOLOGY, 2007, 556 (1-3) :75-83
[10]  
DAndre S., 2021, INTEGR CANCER THER, V20, p15347354211061739, DOI DOI 10.1177/15347354211061739