Highlights Control of chemotherapy-induced nausea and vomiting is inadequate. This phase II crossover randomised controlled trial compared oral cannabis extract or placebo together with guideline-recommended antiemetics. There was a significant improvement in the control of chemotherapy-induced nausea and vomiting. Although there were additional side-effects, most participants preferred cannabis extract to placebo. Based on these positive results, the definitive parallel phase III trial component continues to recruit. Background This multicentre, randomised, double-blinded, placebo-controlled, phase II/III trial aimed to evaluate an oral THC:CBD (tetrahydrocannabinol:cannabidiol) cannabis extract for prevention of refractory chemotherapy-induced nausea and vomiting (CINV). Here we report the phase II component results. Patients and methods...