PMID- 21039759 OWN - NLM STAT- MEDLINE DCOM- 20110224 LR - 20220408 IS - 1365-2125 (Electronic) IS - 0306-5251 (Print) IS - 0306-5251 (Linking) VI - 70 IP - 5 DP - 2010 Nov TI - Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting. PG - 656-63 LID - 10.1111/j.1365-2125.2010.03743.x [doi] AB - 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 Only one patient in the CBM arm was withdrawn due to AEs.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. CI - (c) 2010 Department of Health, Generalitat of Catalonia. British Journal of Clinical Pharmacology (c) 2010 The British Pharmacological Society. FAU - Duran, Marta AU - Duran M AD - Fundacio Institut Catala de Farmacologia, Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain. FAU - Perez, Eulalia AU - Perez E FAU - Abanades, Sergio AU - Abanades S FAU - Vidal, Xavier AU - Vidal X FAU - Saura, Cristina AU - Saura C FAU - Majem, Margarita AU - Majem M FAU - Arriola, Edurne AU - Arriola E FAU - Rabanal, Manel AU - Rabanal M FAU - Pastor, Antoni AU - Pastor A FAU - Farre, Magi AU - Farre M FAU - Rams, Neus AU - Rams N FAU - Laporte, Joan-Ramon AU - Laporte JR FAU - Capella, Dolors AU - Capella D LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Br J Clin Pharmacol JT - British journal of clinical pharmacology JID - 7503323 RN - 0 (Antiemetics) RN - 0 (Antineoplastic Agents) RN - 19GBJ60SN5 (Cannabidiol) RN - 7J8897W37S (Dronabinol) SB - IM MH - Administration, Oral MH - Adult MH - Aged MH - Antiemetics/pharmacokinetics/*therapeutic use MH - Antineoplastic Agents/adverse effects MH - Cannabidiol/pharmacokinetics/*therapeutic use MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Dronabinol/*analogs & derivatives/pharmacokinetics/*therapeutic use MH - Female MH - Humans MH - Male MH - Middle Aged MH - Nausea/chemically induced/*drug therapy MH - Pilot Projects MH - Vomiting/chemically induced/*drug therapy PMC - PMC2997305 EDAT- 2010/11/03 06:00 MHDA- 2011/02/25 06:00 PMCR- 2011/11/01 CRDT- 2010/11/03 06:00 PHST- 2010/11/03 06:00 [entrez] PHST- 2010/11/03 06:00 [pubmed] PHST- 2011/02/25 06:00 [medline] PHST- 2011/11/01 00:00 [pmc-release] AID - 10.1111/j.1365-2125.2010.03743.x [doi] PST - ppublish SO - Br J Clin Pharmacol. 2010 Nov;70(5):656-63. doi: 10.1111/j.1365-2125.2010.03743.x.