title: Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled clinical trial from the Cannabis-In-Cachexia-Study-Group.
abstract: OBJECTIVE
  To compare the effects of cannabis extract (CE), delta-9-tetrahydrocannabinol (THC), and placebo (PL) on appetite and quality of life (QOL) in patients with cancer-related anorexia-cachexia syndrome (CACS).
  
  
  METHODS
  Adult patients with advanced cancer, CACS, weight loss (> or = 5% over 6 months), and Eastern Cooperative Oncology Group (ECOG) performance status (PS) < or = 2 were randomly assigned (2:2:1) to receive CE (standardized for 2.5 mg THC and 1 mg cannabidiol) or THC (2.5 mg) or PL orally, twice daily for 6 weeks. Appetite, mood, and nausea were monitored daily with a visual analog scale (VAS); QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (composite score: questions 29 and 30). Cannabinoid-related toxicity was assessed every 2 weeks.
  
  
  RESULTS
  Of 289 patients screened, 243 were randomly assigned and 164 (CE, 66 of 95 patients; THC, 65 of 100 patients; and PL, 33 of 48 patients) completed treatment. At baseline, groups were comparable for age (mean, 61 years), sex (54% men), weight loss (32% > or = 10%), PS (13% ECOG = 2), antineoplastic treatment (50%), appetite (mean VAS score, 31/100 mm), and QOL (mean score, 30/100). Intent-to-treat analysis showed no significant differences between the three arms for appetite, QOL, or cannabinoid-related toxicity. Increased appetite was reported by 73%, 58%, and 69% of patients receiving CE, THC, or PL, respectively. An independent data review board recommended termination of recruitment because of insufficient differences between study arms.
  
  
  CONCLUSIONS
  CE at the oral dose administered was well tolerated by these patients with CACS. No differences in patients' appetite or QOL were found either between CE, THC, and PL or between CE and THC at the dosages investigated.
authors.affiliation: Division of Oncology/Hematology, Department of Internal Medicine, Cantonal Hospital, St Gallen, Switzerland. florian.strasser@kssg.ch
authors.forename: Florian
authors.initials: F
authors.lastname: Strasser
authors.forename: Diana
authors.initials: D
authors.lastname: Luftner
authors.forename: Kurt
authors.initials: K
authors.lastname: Possinger
authors.forename: Gernot
authors.initials: G
authors.lastname: Ernst
authors.forename: Thomas
authors.initials: T
authors.lastname: Ruhstaller
authors.forename: Winfried
authors.initials: W
authors.lastname: Meissner
authors.forename: You-Dschun
authors.initials: YD
authors.lastname: Ko
authors.forename: Martin
authors.initials: M
authors.lastname: Schnelle
authors.forename: Marcus
authors.initials: M
authors.lastname: Reif
authors.forename: Thomas
authors.initials: T
authors.lastname: Cerny
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000855:Anorexia / Q000188:drug therapy* / Q000209:etiology; D001066:Appetite / Q000187:drug effects; D019167:Appetite Stimulants / Q000627:therapeutic use*; D002100:Cachexia / Q000188:drug therapy* / Q000209:etiology; D002188:Cannabis; D004311:Double-Blind Method; D013759:Dronabinol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D008517:Phytotherapy / Q000379:methods; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D019167:Appetite Stimulants; D010936:Plant Extracts; D013759:Dronabinol