title: A double-blind, placebo-controlled, crossover pilot trial with extension using an oral mucosal cannabinoid extract for treatment of chemotherapy-induced neuropathic pain.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Pain Management Unit, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Anesthesia, Psychiatry and Pharmacology, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: mary.lynch@dal.ca.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Lynch
authors.affiliation: Division of Gynecologic Oncology, Dalhousie University, Halifax, Nova Scotia, Canada.
authors.forename: Paula
authors.initials: P
authors.lastname: Cesar-Rittenberg
authors.affiliation: Department of Psychological and Brain Sciences, Indiana University, Bloomington, Indiana, USA.
authors.forename: Andrea G
authors.initials: AG
authors.lastname: Hohmann
mesh_terms: D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002185:Cannabidiol / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D013759:Dronabinol / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000139:chemically induced* / Q000188:drug therapy*; D058993:Oral Sprays; D010147:Pain Measurement; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000970:Antineoplastic Agents; D004338:Drug Combinations; D058993:Oral Sprays; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols
keywords: Neuropathic pain; cannabinoids; chemotherapy; randomized controlled trial