Pilot and definitive randomised double-blind placebo-controlled trial evaluating an oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting.

See ANZCTR for full trial details >

View the lay summary >

View the media release about recent pilot phase II results >

Trial summary:

This trial aims to determine if an anti-emetic regimen incorporating oral tetra-hydrocannabinol (THC)/ cannabidiol (CBD) is more effective than a guideline-consistent anti-emetic regimen for the secondary prevention of chemotherapy-induced nausea and vomiting (CINV), during 3 consecutive cycles of chemotherapy.

View the lay summary.

Supported By:

NSW Health, NHMRC Clinical Trials Centre (USYD) and Tilray

Eligibility:

Patients aged ≥18 years with known malignancy of any stage, requiring  ≥ 2 further cycles of moderate to highly emetogenic intravenous chemotherapy and experiencing significant CINV during previous cycles

Objectives:

To compare, amongst patients randomised to oral THC/CBD or placebo, the ability to control emesis and nausea

Registration ID:

ACTRN12616001036404

Participation:

Australia

Australian Lead Group:

NHMRC Clinical Trial Centre (USYD)

In collaboration with Chris O’Brien Lifehouse and the Lambert Initiative for Cannabinoid Therapeutics (USYD)

Status:

Recruiting

Activation Date:

16 September 2016 (HREC Approval)

Chairs:

Clinical Associate Professor Peter Grimison

Contact:

cannabisCINV@ctc.usyd.edu.au