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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.
Results
Results published in Annals of Oncology found a significant improvement in the control of chemotherapy-induced nausea and vomiting. A quarter of the patients taking medicinal cannabis experienced no vomiting and nausea, compared to 14 per cent of people who took a placebo.
Overview
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. |
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: |
See ANZCTR for full trial details >