Pilot trials evaluating an oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting (the cannabis CINV trial).

Chemotherapy-induced nausea and vomiting (CINV) remains a significant cause of morbidity despite best current anti-emetic prophylaxis. Limited evidence suggests cannabinoid medicine (THC, CBD) may assist in control of CINV and this study is exploring this through a pilot definitive randomised double-blind placebo-controlled trials evaluating an oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of CINV. The aim of the study is to determine if an anti-emetic regimen incorporating oral THC/CBD is more effective than a guideline-consistent anti-emetic regimen for the secondary prevention of CINV, during any three consecutive cycles of chemotherapy (A, B, C). Patients aged 18 years or older with known malignancy of any stage receiving moderate-to-highly emetogenic intravenous chemotherapy, requiring 2 or more further cycles of chemotherapy, and experiencing significant CINV are recruited for the trial. A within-trial and modelled economic evaluation is undertaken to determine the incremental cost-effectiveness of oral cannabinoid therapy compared to placebo and other anti-emetic therapies, from a health system perspective.

 

Collaborators:

Sydney Local Health District, Cancer Research Institute, University of South Australia, Calvary Mater Hospital Newcastle, University of Sydney, Lifehouse Partnership Council

Funded by:

NHMRC Clinical Trials Centre
Chris O’Brien Lifehouse
Lambert Initiative for cannabinoid therapeutics
Health Administration Corporation
Tilray

Chief investigators:

John Simes, Rachael L Morton, Peter Grimison, Paul Haber, Iain McGregor, David Allsop, Ian Olver, Craig Gedye, Jennifer Martin, Andrew Dawson

Trial registration number:

ACTRN12616001036404

Contact:

healtheconomics@ctc.usyd.edu.au