CARE NSW (Cannabinoids for Symptom Control in Advanced Cancer, an Open Label Prospective Clinical Trial in NSW) is currently the largest investigator led medicinal cannabis trial in advanced cancer world-wide, enabling NSW to be a world leader in clinical research of cannabis medicines.
The data collected will strengthen the internal evidence-base on cannabis medicines to enable timely translation into clinical practice, direct the Australian-focus on medicinal cannabis research, improve consumer knowledge, and provide GPs with prescriber confidence.
About the CARE NSW Trial for advanced cancer patients
CARE NSW is a statewide trial, sponsored and funded by the NSW Government through the NSW Clinical Cannabis Medicines Program. The trial will provide legal access to cannabis medicines for 600 patients in NSW who experience uncontrolled pain, nausea or anorexia as a symptom of their advanced cancer.
The CARE NSW Trial is an open label study, with the main purpose of determining what dose and frequency of medicinal cannabis is the best to relieve key symptoms in people with advanced cancer.
Treatment will be with oral oil liquids, either predominantly Delta-9-Tetrahydrocannabinol (THC) or a combination of THC and Cannabidiol (CBD) in near equal amounts. The choice of cannabis medicine will be guided by each participant’s primary symptoms and at the discretion of the doctor and supply.
The cannabis medicine will be given in addition to the usual treatments for advanced cancer symptoms, and will be prescribed and supplied to trial participants at no cost until they withdraw from the trial or are no longer able to take it.
The trial is being conducted in accordance with the standard ethical process for clinical trials and has received regulatory approval. It has been reviewed and approved by an appropriate Human Research Ethics Committee.
Professor Jennifer Martin, Clinical Pharmacologist, General Physician and Director of the Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), within the University of Newcastle is leading the trial alongside a research team of specialists in cancer, palliative care, public health, addiction medicine, pharmacology and toxicology. ACRE is funded through the National Health and Medical Research Council’s Centre of Research Excellence scheme.
Participating in the CARE NSW Trial
The trial has strict eligibility criteria. Patients will be screened before being admitted to the trial to ensure it is safe and appropriate for them to participate.
Participants will be advanced cancer patients aged 18 years and older, with symptoms (individual or multiple) of anorexia, nausea or refractory pain not responsive to current therapies and with 3-12 months life expectancy.
Any patients interested in participating in the CARE NSW Trial should speak to their doctor. A doctor can review the trial details publicly available and confirm if the CARE NSW Trial may be a suitable option. A doctor may refer a patient directly to the trial site most suitable for them to attend.
The full inclusion criteria for the trial is publicly available on the Australian and New Zealand Clinical Trials Registry (ANZCTR) under Cannabinoids for Symptom Control in Advanced Cancer, an Open Label Prospective Clinical Trial in New South Wales (NSW).
Health professionals can also refer to the ClinTrial Refer mobile application for more detailed information and trial site contact details, or find more information in the CARE NSW Trial - Information for Health Professionals factsheet.
The first site, Orange Health Service, commenced recruiting patients in February 2020. Additional cancer centres across regional and metropolitan NSW have since commenced recruitment, and further centres are anticipated to open in 2021.
A list of current trial sites can be on ACRE's website.