Chemotherapy-induced nausea and vomiting


This NSW Government-funded trial is the largest, most definitive clinical trial ever undertaken evaluating the potential of a cannabis medicine to prevent nausea and vomiting in patients undergoing chemotherapy.

 

Background

To date, studies in the area of chemotherapy-induced nausea and vomiting have been carried out using smoked cannabis or oral synthetic cannabis medicines, with most studies featuring very small numbers of participants. To assess the effectiveness of these cannabis medicines, the trials compared them with outdated antiemetic (anti-vomiting) medical treatments.

Modern antiemetic medical treatments have significantly reduced these unpleasant symptoms, but approximately half of all people undergoing potent intravenous chemotherapy still experience nausea and one-third still experience vomiting.

About the chemotherapy-induced nausea and vomiting trial

The trial being funded by the NSW Government plays a critical role in developing a better understanding of how cannabis medicines may provide relief from the symptoms in patients undergoing potent intravenous chemotherapy, where standard treatments have proven ineffective. It is also assessing any side effects that occur during the treatment course. This study consists of two stages: a pilot phase II study and a definitive phase III trial with a total of 250 patients enrolled.

The clinical trial is using an oral, plant-derived, pharmaceutical-grade capsule containing a consistent ratio of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), developed by a Canadian cannabis-medicine company.

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.

Clinical Associate Professor Peter Grimison is a medical oncologist from Chris O’Brien Lifehouse and The University of Sydney and is leading the trial alongside a research team of specialists in cancer, addiction medicine and clinical toxicology.

Participating in the chemotherapy-induced nausea and vomiting trial

The trial has strict eligibility criteria. Patients will be screened before being admitted to the trial to ensure that it is safe and appropriate for them to participate.

Participants must be over 18, undergoing intravenous chemotherapy for cancer, and have significant symptoms during treatment despite being given the best standard of care.

See the fact sheet below for further information on eligibility requirements.

Updates

The first (pilot) stage is enrolling and treating up to 80 patients at Chris O’Brien Lifehouse and nine other leading NSW cancer centres: Concord Hospital, Calvary Mater Newcastle, Campbelltown Hospital, Coffs Harbour Hospital, Orange Health Service, Wollongong Hospital, Nepean Hospital, Royal North Shore Hospital and Port Macquarie Base Hospital. The first site commenced recruiting patients in November 2016.

Two additional cancer centres – Calgary Riverina Hospital and Tweed Hospital – were activated in November 2018 and have commenced patient recruitment. Three other cancer centres in NSW are expected to be activated in the first quarter of 2019.

The second stage is a randomised controlled trial expected to enrol up to a further 170 patients. This second stage is expected to commence in early to mid-2019.

Continued free treatment after the trial

The trial has been specifically designed to allow a patient continued access, free of charge, to the cannabis medicine after they have concluded the trial. First, a statistician reviews the patient data to determine if they were receiving the cannabis medicine or the placebo. If they were receiving the medicine and it proved effective, the patient will be supplied sufficient cannabis medicine for all subsequent cycles of that specific chemotherapy treatment.