Strasser, F., Luftner, D., Possinger, K., Ernst, G., Ruhstaller, T., Meissner, W., . . . Cerny, T. (2006). Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: A multi-center, phase III, randomized, double-blind, placebo-controlled clinical trial from the Cannabis-In-Cachexia-Study-Group. Journal of Clinical Oncology, 24, 3394–3400.doi: 10.1200/JCO.2005.05.1847
After 7–14 days of baseline assessment, patients were randomized to treatment with cannabis extract (CE) (standardized for 2.5 mg of delta-9-tetrahydrocannabinol [THC] and 1 mg of cannabinoid) or THC (2.5 mg), or placebo.
Assessments were performed every two weeks during clinic visits at screening, and patients maintained a diary at weeks two, four, and six.
The study was conducted in 30 centers in Germany, Switzerland, and the Netherlands.
A multicenter, phase III, randomized, double-blind, placebo-controlled, parallel study design was used.
No differences between groups were noted at baseline in terms of age, sex, weight loss, performance status, antineoplastic treatment, appetite, or QOL. Intent-to-treat analysis showed no significant differences between the three arms for appetite, QOL, or cannabinoid-related toxicity. An independent data review board recommended termination of recruitment because of insufficient differences between study arms.
Researchers concluded that there was no difference in either appetite or QOL outcomes between the CE, THC, or placebo groups.