Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting (CINV): a randomised, placebo-controlled, phase 2 crossover trial
Mené sur 81 patients atteints d’un cancer (âge médian :55 ans), cet essai de phase II évalue l’efficacité du cannabis thérapeutique dispensé par voie orale pour prévenir les nausées et vomissement induits par une chimiothérapie
Background : This multi-centre, randomised, double-blinded, placebo-controlled, phase 2/3 trial is aimed to evaluate an oral THC:CBD cannabis extract for prevention of refractory CINV. Here we report the phase 2 component results. Patients and methods : Eligible patients experienced CINV during moderate-highly emetogenic intravenous chemotherapy despite guideline-consistent anti-emetic prophylaxis. Study treatment consisted of 1 cycle of 1-4 self-titrated capsules oral THC 2.5mg/CBD 2.5mg (TN-TC11M) three times daily, days -1 to 5 and 1 cycle of matching placebo in a crossover design, then blinded patient preference for a 3rd cycle. The primary endpoint was the proportion of participants with complete response during 0-120 hours from chemotherapy. 80 participants provided 80% power to detect a 20% absolute improvement with a 2-sided p-value of 0.1. Results : 81 participants were randomised; 72 completing 2 cycles are included in the efficacy analyses and 78 not withdrawing consent are included in safety analyses. Median age was 55 years (range 29-80). 78% were female. Complete response was improved with THC:CBD from 14% to 25% (RR 1.77, 90% CI 1.12, 2.79, P=0.041), with similar effects on absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE). 31% experienced moderate or severe cannabinoid-related adverse events such as sedation, dizziness, disorientation; but 83% of participants preferred cannabis to placebo. No serious adverse events were attributed to THC:CBD. Conclusion : The addition of oral THC:CBD to standard anti-emetics was associated with less nausea and vomiting but additional side effects. Most participants preferred THC:CBD to placebo. Based on these promising results, we plan to recruit an additional 170 participants to complete accrual for the definitive, phase 3, parallel group analysis.
Annals of Oncology 2020