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Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting.
Br J Clin Pharmacol 2010; 70(5):656-63BJ

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 Only one patient in the CBM arm was withdrawn due to AEs.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.

Authors+Show Affiliations

Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21039759

Citation

Duran, Marta, et al. "Preliminary Efficacy and Safety of an Oromucosal Standardized Cannabis Extract in Chemotherapy-induced Nausea and Vomiting." British Journal of Clinical Pharmacology, vol. 70, no. 5, 2010, pp. 656-63.
Duran M, Pérez E, Abanades S, et al. Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting. Br J Clin Pharmacol. 2010;70(5):656-63.
Duran, M., Pérez, E., Abanades, S., Vidal, X., Saura, C., Majem, M., ... Capellà, D. (2010). Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting. British Journal of Clinical Pharmacology, 70(5), pp. 656-63. doi:10.1111/j.1365-2125.2010.03743.x.
Duran M, et al. Preliminary Efficacy and Safety of an Oromucosal Standardized Cannabis Extract in Chemotherapy-induced Nausea and Vomiting. Br J Clin Pharmacol. 2010;70(5):656-63. PubMed PMID: 21039759.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting. AU - Duran,Marta, AU - Pérez,Eulàlia, AU - Abanades,Sergio, AU - Vidal,Xavier, AU - Saura,Cristina, AU - Majem,Margarita, AU - Arriola,Edurne, AU - Rabanal,Manel, AU - Pastor,Antoni, AU - Farré,Magí, AU - Rams,Neus, AU - Laporte,Joan-Ramon, AU - Capellà,Dolors, PY - 2010/11/3/entrez PY - 2010/11/3/pubmed PY - 2011/2/25/medline SP - 656 EP - 63 JF - British journal of clinical pharmacology JO - Br J Clin Pharmacol VL - 70 IS - 5 N2 - 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. SN - 1365-2125 UR - https://www.unboundmedicine.com/medline/citation/21039759/abstract/Preliminary_efficacy_and_safety_of_an_oromucosal_standardized_cannabis_extract_in_chemotherapy_induced_nausea_and_vomiting_ L2 - https://doi.org/10.1111/j.1365-2125.2010.03743.x DB - PRIME DP - Unbound Medicine ER -