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Clinical Trial
. 2010 Nov;70(5):656-63.
doi: 10.1111/j.1365-2125.2010.03743.x.

Preliminary Efficacy and Safety of an Oromucosal Standardized Cannabis Extract in Chemotherapy-Induced Nausea and Vomiting

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Free PMC article
Clinical Trial

Preliminary Efficacy and Safety of an Oromucosal Standardized Cannabis Extract in Chemotherapy-Induced Nausea and Vomiting

Marta Duran et al. Br J Clin Pharmacol. .
Free PMC article

Abstract

Aims: Despite progress in anti-emetic treatment, many patients still suffer from chemotherapy-induced nausea and vomiting (CINV). This is a pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of an acute dose titration of a whole-plant cannabis-based medicine (CBM) containing delta-9-tetrahydrocannabinol and cannabidiol, taken in conjunction with standard therapies in the control of CINV.

Methods: Patients suffering from CINV despite prophylaxis with standard anti-emetic treatment were randomized to CBM or placebo, during the 120 h post-chemotherapy period, added to standard anti-emetic treatment. Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs). The endpoint for the preliminary efficacy analysis was the proportion of patients showing complete or partial response.

Results: Seven patients were randomized to CBM and nine to placebo. Only one patient in the CBM arm was withdrawn due to AEs. A higher proportion of patients in the CBM group experienced a complete response during the overall observation period [5/7 (71.4%) with CMB vs. 2/9 (22.2%) with placebo, the difference being 49.2% (95% CI 1%, 75%)], due to the delayed period. The incidence of AEs was higher in the CBM group (86% vs. 67%). No serious AEs were reported. The mean daily dose was 4.8 sprays in both groups.

Conclusion: Compared with placebo, CBM added to standard antiemetic therapy was well tolerated and provided better protection against delayed CINV. These results should be confirmed in a phase III clinical trial.

Figures

Figure 1
Figure 1
Study flow chart. *Excluded: 11 patients had an exclusion criteria (participation in other clinical trials, 5; use of cannabinoids during the previous 30 days, 1; illicit drug use during the previous 30 days, 1; psychiatric disease, 1; end of chemotherapy 1; did not understood the language, 2); 23 patients declined to participate because the study drug was only administered in one cycle. **ITT: intention-to –treat
Figure 2
Figure 2
Plasma concentration of CBM active components and metabolites at each point of extraction. CBD (formula image); THC (formula image); 11-OH-THC (formula image); THC-COOH (formula image)

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