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.

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 reported on 243 randomly assigned adult patients with advanced cancer.
• Patients had cancer-related anorexia-cachexia syndrome, weight loss of more than 5% over six months, and an Eastern Cooperative Oncology Group performance status of 2 or less.
• A total of 164 patients completed treatment.

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.

• Appetite was measured using a visual analog scale (VAS), with 0 mm indicating the worst and 100 mm indicating the best; appetite values were calculated as the mean of daily appetite scores for the seven days of week two in each biweekly period.
• Patients’ estimation of food intake was measured daily using a VAS.
• Mood was assessed using a VAS monitored daily.
• Nausea was assessed using a VAS monitored daily.
• Quality of life (QOL) was assessed using questions on global health status and QOL on the European Organization for Research and Treatment Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) transformed into a single functional scale ranging from 0–100.

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.

• The study lacks a constitutive definition of anorexia.
• Adverse events included nausea, fatigue, pain, anemia, dizziness, dyspnea, diarrhea, and constipation.
• The multicenter design (n = 30) may have contributed to some of the variation in data, although statistical procedures were used to address this limitation, and investigators were trained in outcome measurement procedures.