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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

Florian Strasser, Diana Luftner, Kurt Possinger, Gernot Ernst, Thomas Ruhstaller, Winfried Meissner, You-Dschun Ko, Martin Schnelle, Marcus Reif, Thomas Cerny

From the Division of Oncology/Hematology, Department of Internal Medicine, Cantonal Hospital, St Gallen, Switzerland; Departments of Medical Oncology and Anesthesiology/Pain Management, University Hospital Charité, Central Campus; Institute for Clinical Research, Berlin; Department of Anesthesiology and Intensive Care, Friedrich-Schiller-University, Jena; and Medizinische Poliklinik, University Hospital, Bonn, Germany

Address reprint requests to Florian Strasser, MD, ABHPM, Oncology and Palliative Medicine, Section of Oncology/Hematology, Department Internal Medicine, Cantonal Hospital, Rorschacherstrasse, 9007 St Gallen, Switzerland; e-mail: florian.strasser{at}kssg.ch

PURPOSE: 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).

PATIENTS AND METHODS: Adult patients with advanced cancer, CACS, weight loss ( 5% over 6 months), and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 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% 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.

CONCLUSION: 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.

Supported by the Institute for Clinical Research (Berlin, Germany), which provided all funding for administrative activities related to the conduct of the trial and for analysis of the data (www.ikf-berlin.de).

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003; and at the International Association for Cannabis as Medicine 2nd Congress on Cannabinoids in Medicine, Cologne, Germany, September 12-13, 2003.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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