Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting

Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.
British Journal of Clinical Pharmacology (Impact Factor: 3.88). 11/2010; 70(5):656-63. DOI: 10.1111/j.1365-2125.2010.03743.x
Source: PubMed


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 Only one patient in the CBM arm was withdrawn due to AEs.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

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    • "These results suggest that allosteric inhibition of 5-HT 3 receptors by CBD may also contribute to modulation of emesis by this agent. There is initial proof that in patients suffering from intractable CINV, addition of Sativex ® (GW Pharmaceuticals , UK), a combination of THC and CBD, during the 5 days postchemotherapy period to the standard antiemetic regime may have a better consequence (Duran et al., 2010). However, longer treatment for 14 days in this combination produced a significant worsening in nausea and vomiting, whereas THC extract did not differ in this respect from placebo (Johnson et al., 2010). "
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    ABSTRACT: Cannabinoids (the active constituents of Cannabis sativa) and their derivatives have got intense attention during recent years because of their extensive pharmacological properties. Cannabinoids first developed as successful agents for alleviating chemotherapy associated nausea and vomiting. Recent investigations revealed that cannabinoids have a wide range of therapeutic effects such as appetite stimulation, inhibition of nausea and emesis, suppression of chemotherapy or radiotherapy-associated bone loss, chemotherapy-induced nephrotoxicity and cardiotoxicity, pain relief, mood amelioration, and last but not the least relief from insomnia. In this exploratory review, we scrutinize the potential of cannabinoids to counteract chemotherapy-induced side effects. Moreover, some novel and yet important pharmacological aspects of cannabinoids such as antitumoral effects will be discussed. Copyright © 2014 John Wiley & Sons, Ltd.
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    • "However, the growing interest in the medical applications of cannabinoids should be accompanied by discussion of their safety and efficacy in older patients (Ahmed et al., 2014). Several randomized clinical trials have demonstrated the safety and efficacy of cannabinoid-based medicines in the treatment of conditions that are common in older individuals (Nelson et al., 2004; Duran et al., 2010; Pickering et al., 2011; Toth et al., 2012). However, most of these trials either did not include older subjects or, if they were included, did not analyze data by age group, which makes it difficult to draw firm conclusions about Table 2 Overview of all 40 drug-related adverse events reported by subjects or observed by investigator during the trail. "
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