A clinical trial involving patients with refractory chemotherapy-induced nausea and vomiting (CINV) showed that the addition of tetrahydrocannabinol-cannabidiol (THC:CBD) cannabis extract to standard anti-emetics was associated with less nausea and vomiting, according to results published in Annals of Oncology.
The crossover trial included 81 patients with refractory CINV who were randomly assigned to either THC:CBD in cycle A followed by placebo in cycle B (n=40) or placebo in cycle A followed by THC:CBD in cycle B (n=41). From these, 72 completed the two cycles and were included in the efficacy analysis, and 78 were included in the safety analysis. The primary endpoint was the proportion of participants with complete response during 0-120 hours from chemotherapy.
Complete response was improved with THC:CBD from 14 to 25 per cent, with similar effects on the absence of emesis, use of rescue medications, absence of significant nausea and summary scores for the Functional Living Index-Emesis (FLIE).
Although almost one-third of participants experienced moderate to severe cannabinoid-related adverse events (such as sedation, dizziness, and disorientation), 85 per cent of participants preferred THC:CBD to placebo.
The authors conclude that when combined with guideline-consistent anti-emetic prophylaxis, oral THC:CBD cannabis extract was active and tolerable in preventing chemotherapy-induced nausea and vomiting.