A Double-Blind, Placebo-Controlled, Crossover Pilot Trial With Extension Using an Oral Mucosal Cannabinoid Extract for Treatment of Chemotherapy-Induced Neuropathic Pain
Open accessAbstract
Context Neuropathic pain caused by chemotherapy limits dosing and duration of potentially life-saving anti-cancer treatment and impairs quality of life. Chemotherapeutic neuropathy responds poorly to conventional treatments, and there is an urgent medical need for new treatments. Recent preclinical studies demonstrate that cannabinoid agonists suppress established chemotherapy-evoked neuropathy.Objectives This was a pilot trial to begin to investigate a currently available cannabinoid agent, nabiximols (oral mucosal spray containing cannabinoids), in the treatment of chemotherapy-induced neuropathic pain.Methods A randomized, placebo-controlled crossover pilot study was done in 16 patients with established chemotherapy-induced neuropathic pain. A 0-10 point numeric rating scale for pain intensity (NRS-PI) was used as the primary outcome measure.Results When examining the whole group, there was no statistically significant difference between the treatment and the placebo groups on the NRS-PI. A responder analysis demonstrated that there were five participants who reported a two-point or greater reduction in pain that trended toward statistical significance and the number needed to treat was five.Conclusion Chemotherapy-induced neuropathic pain is particularly resistant to currently available treatments. This pilot trial found a number needed to treat of five and an average decrease of 2.6 on an 11-point NRS-PI in five "responders" (as compared with a decrease of 0.6 with placebo) and supports that it is worthwhile to study nabiximols in a full randomized, placebo-controlled trial of chemotherapy-induced neuropathic pain.
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In a pilot study of chemotherapy-induced neuropathic pain, no statistically significant difference in pain scores was found in the oromucosal-treated group compared to placebo, although five of 16 participants reported a 2-point grade reduction of pain score.
“In a pilot study of chemotherapy-induced neuropathic pain, no statistically significant difference in pain scores was found in the oromucosal-treated group, as compared to the placebo group, although five of the 16 participants reported a 2-point grade reduction of pain score (Lynch et al, 2014).”
From The endogenous cannabinoid system: a budding source of targets for treating inflammatory and neuropathic pain (2018) · cites this paper as Lynch et al, 2014
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- Authors
- Lynch, M. E., Cesar-Rittenberg, P., & Hohmann, A. G.
- Affiliations
- Dalhousie University (CA)
- Indiana University Bloomington (US)
- Corresponding author
- Lynch, Mary E.
- Venue
- Journal of Pain and Symptom Management
- Publisher
- Elsevier BV
- Published
- 2014-01
- Volume
- 47
- Issue
- 1
- Pages
- 166-173
- ISSN
- 0885-3924 (ISSN-L)
- OpenAlex
- W2083316585
- Cited by
- 266
- References
- 22
- Citations by year
- 2026: 10 · 2025: 15 · 2024: 22 · 2023: 24 · 2022: 42 · 2021: 33 · 2020: 34 · 2019: 26 · 2018: 20 · 2017: 11 · 2016: 13 · 2015: 6 · 2014: 9 · 2013: 1
- FWCI
- 5.17
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Pain and Symptom Management (publishedVersion)
- PubMed (publishedVersion)
- Funders
- GW Pharmaceuticals
- National Institute on Drug Abuse (RC1DA028200)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
- Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Keywords
- chemotherapy-induced neuropathic pain, nabiximols, cannabinoid receptor agonists, chemotherapy-induced peripheral neuropathy, pain intensity, number needed to treat
- MeSH terms
- Analgesics, Antineoplastic Agents, Cannabidiol, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Neuralgia, Pain Measurement, Pilot Projects, Dronabinol, Treatment Outcome, Cross-Over Studies, Oral Sprays
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