This trial is part of the NSW Government’s commitment to develop a better understanding of how cannabis products can provide relief to patients with terminal illness. This trial is separate to the Terminal Illness Cannabis Scheme.
The research team, led by Associate Professor Meera Agar from the University of New South Wales, will conduct the clinical trial on the use of medicinal cannabis to improve the quality of life of people with terminal cancer.
The goal of the trial is to assess whether medicinal cannabis products can enhance the quality of life for adults with terminal cancer in their final stages of life, particularly by improving appetite and appetite-related symptoms. The trial will be undertaken in two parts.
The first part of the trial, known as a Phase II study, will enrol approximately 30 patients in order to answer 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?
Part one of the trial will be conducted at the Calvary Mater Newcastle Hospital. Patients will begin treatment in early 2016 with initial results expected by the end of 2016.
The second part of the trial, known as a Phase III study, will be informed by the results of Phase II and may enrol a larger number of patients in a number of major hospitals across NSW. In this part of the trial, it is intended to randomly assign patients to three groups. Each group will receive either a cannabis product or a placebo. All patients will be closely monitored and data will be collected to look for differences between the groups. This will allow researchers to see whether patients who received a cannabis product had outcomes that were better, worse or the same as patients who did not receive a cannabis product.
The trial will be reviewed by an ethics committee and conducted in accordance with the standard ethical process for clinical trials. Part two will begin by the end of 2016.
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. Enrolment of patients for part one will take place at the Calvary Mater Newcastle Hospital. Information on the process for enrolment will be made available in due course. Any enquiries about the trial can be addressed to email@example.com or
Cannabis Trials, NSW Ministry of Health, Locked Mail Bag 961, North Sydney, NSW 2059.