This is the first time in Australia that a vaporised cannabis flower bud will be used in a clinical trial to develop a better understanding of how it may provide relief to adult cancer patients in the final stages of life.
It is separate to the Medicinal Cannabis Compassionate Use Scheme (formerly known as the Terminal Illness Cannabis Scheme or TICS), administered by the NSW Department of Justice.
About the trial
The goal of the trial is to assess whether medicinal cannabis products can enhance the quality of life for adults with advanced cancer, particularly by improving appetite and appetite-related symptoms.
The trial will play a critical role in helping to answer important questions about safety, efficacy, dosage and frequency, side effects and what the best delivery mode might be for palliative care patients.
Led by UNSW Professor Meera Agar in collaboration with researchers from several universities, the first stage of the trial will enrol about 30 patients with advanced cancer and take place at Sacred Heart Health Service, St Vincent’s Hospital, Sydney, and Calvary Mater Newcastle hospital.
The first part of the trial will assess the following questions:
- Can a potential cannabis product be successfully given to patients by inhaling it as a vapour?
- Is the potential cannabis product well tolerated by patients, that is, does it cause any unwanted side effects?
- What is the ideal dose of the potential cannabis product and how often should it be given?
Depending on the results, the second part may then enrol up to 250 more patients at several metropolitan and regional hospitals in NSW in a double-blind randomised controlled trial.
The cannabis flower bud used in the first part of the trial has been produced by Bedrocan BV®, a medicinal cannabis company in The Netherlands.
Participating in the trial
Only patients with advanced cancer who are over 18 years of age and who meet specific additional criteria can be considered for enrolment.
Participants will be administered varying doses of vaporised cannabis flower bud (Bedrobinol® 13.5% THC) one hour before meals three times a day for a period of seven days, unless side effects occur.
Participants will have blood samples taken at multiple time points up to four hours following each morning dose to determine the concentration of the drug in the blood. They will also be asked to complete questionnaires and a daily food record to monitor the effect on appetite, mood and other factors.
For information on the process for enrolment, please contact your treating oncologist or palliative care specialist to discuss the eligibility criteria.
For more general information on the trials:
- call the Cannabis Trials Help Line on 1800 217 257
- write to Cannabis Trials, NSW Ministry of Health, Locked Mail Bag 961, North Sydney, NSW 2059
- email the NSW Ministry of Health firstname.lastname@example.org
For more information about cancer services in NSW visit the Cancer Institute NSW website www.cancerinstitute.org.au