Clinical Trials 

Australian-based clinical trials in cannabinoids currently managed by ACRE Investigators and our Affiliated Researchers.

 

CARE NSW [Advanced Cancer] 

CARE NSW Trial is a multi-site, state-wide clinical trial which will enrol 600 patients in metropolitan and regional centres across NSW. It is open to both men and women with advanced cancer who experience uncontrolled symptoms of pain and/or nausea and/or anorexia. The CARE NSW Trial will investigate the dose of cannabis medicines that provides effective control of symptoms in the advanced cancer population.

SCIENTIFIC TITLE 

Cannabinoids for Symptom Control in Advanced Cancer, an Open Label Prospective Clinical Trial in NSW.

DISEASE TYPE 

Advanced Cancer

SUMMARY

CARE NSW Trial is an open label, prospective, Phase IV trial (which includes a Phase II pharmacokinetic component) to assess the safety and effectiveness of a range of cannabis medicines on key symptoms in advanced cancer and the best dose and frequency of the cannabis medicine for symptom control. Gathering this evidence in terms of patient outcomes, and understanding side effects and drug-drug interactions, will guide the future prescribing of cannabis medicines for advanced cancer patients.

Patients with advanced cancer who experience uncontrolled symptoms of pain and/or nausea and/or anorexia as well as meet the inclusion criteria are invited to participate.

All participants will be prescribed a cannabis medicine from a range of oral medicinal cannabis oils registered for human use in Australia. The cannabis medicines will be either predominantly Delta-9-Tetrahydrocannabinol (THC) or a combination of THC and Cannabidiol (CBD) in near equal amounts.

Patients will be prescribed these oils at no cost until they withdraw from the study or are no longer able to take them. Treatment will be given in addition to the patient’s usual medical treatments for advanced cancer and symptom control. Prior or current use of medicinal cannabis is not an exclusion to participate.

Participants will need to attend their local site every few weeks for clinical assessments, blood tests and to complete surveys on how they feel. They will also complete a daily patient diary via a mobile phone application.

CARE NSW is sponsored and funded by the Health Administration Corporation, acting through the NSW Ministry of Health. It is coordinated by Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE) which is responsible for the day-to-day management and oversight of the study. The study is led by Professor Jennifer Martin alongside a research team of specialists in cancer, palliative care, public health, addiction medicine, pharmacology and toxicology.

CARE NSW will recruit 600 participants over three years and is expected to involve at least 10 hospitals from across the state. 

FOR HEALTH PROFESSIONALS

If you are interested in referring participants to CARE NSW, please see the trial registration for Cannabinoids for Symptom Control in Advanced Cancer, an Open Label Prospective Clinical Trial in New South Wales (NSW) or CARE NSW Trial Information for Health Professionals Fact Sheet for further information. 

FOR CONSUMERS 

If you think this trial is relevant to your situation, please contact your cancer specialist to discuss further.

PARTICIPATING CENTRES

NSW

Orange Base Hospital

ACRE • All Right Reserved

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