CLINICAL TRIALS

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

 


CARE NSW [Advanced Cancer]

The CARE NSW Trial is a multi-site, state-wide clinical trial which will enrol up to 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 information collected in CARE NSW will guide the future use of cannabis medicines to control symptoms in people with advanced cancer.

SCIENTIFIC TITLE 

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

DISEASE TYPE 

Advanced Cancer

SUMMARY

The CARE NSW Trial is an open-label, prospective, Phase IV trial (which includes a Phase II pharmacokinetic component) to assess the safety and efficacy of a range of cannabis medicines on key symptoms experienced by patients with advanced cancer. This study also aims to identify the best dose and frequency of the cannabis medicine for symptom control. Gathering this evidence will guide the future prescribing of cannabis medicines for patients with advanced cancer.

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 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.

Participants 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 participant’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, have several blood tests, and to complete surveys on how they feel. They will also complete a patient diary via a mobile phone application.

The CARE NSW Trial is sponsored and funded by the Health Administration Corporation, acting through the NSW Ministry of Health. It is coordinated by the 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 up to 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 the CARE NSW Trial, 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 the 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.

CURRENT PARTICIPATING CENTRES (NSW only)

  • Orange Health Service
  • Chris O’Brien Lifehouse
  • Liverpool Hospital
  • Tamworth Hospital
  • Prince of Wales Hospital

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