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.
The trial plays a critical role in developing a better understanding of how cannabis medicines may provide relief from these 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.
To date, studies in this area 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 To assess the effectiveness of these cannabis medicines, the trials compared them with outdated antiemetic (anti-vomiting) medical treatments.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. This trial aims to assess if capsules of pharmaceutical-grade, cannabis-rich oil can bring patients symptom relief where conventional medical approaches have failed.
Clinical Associate Professor Peter Grimison is a medical oncologist from Chris O’Brien Lifehouse and The University of Sydney. Associate Professor Grimison is leading a research team of specialists in cancer, addiction medicine and clinical toxicology.
The trial is part of a $9 million commitment by the NSW Government toward clinical trials evaluating the safety and effectiveness of cannabis medicines in preventing chemotherapy-induced nausea and vomiting in patients undergoing chemotherapy, enhancing appetite and appetite-related symptoms in palliative care patients with advanced cancer and reducing seizures in children with severe, treatment-resistant epilepsy.
Trial underway across 10 sites
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 and the last in June 2017.
If the pilot stage proves to be safe and effective, as measured by the percentage of patients who gain complete relief from their nausea and vomiting, it will be followed by a double-blind randomised controlled trial expected to enrol up to a further 250 patients. This second stage is expected to commence in early 2018, potentially expanding to a number of additional sites.
The research will be 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.
Many patients undergoing potent intravenous chemotherapy respond well to the standard therapies to prevent any nausea and vomiting that may accompany this important cancer treatment. However, about half of people do not gain relief from significant nausea and around one-third of all patients still experience vomiting.
People who continue to have these symptoms during chemotherapy, despite being given best standard care, may be invited to join the trial.
Participants must be over 18 years of age, be undergoing chemotherapy for cancer and have significant symptoms during chemotherapy despite being given the best standard of care.
Participants visit the trial clinic over a period of about three months. After enrolment, they begin taking the cannabis medicine or placebo the day before they commence their first chemotherapy cycle, and continue taking it for five days after that cycle.
Participants will remain on the study for three consecutive cycles of chemotherapy treatment (between six and nine weeks). After completing three cycles of chemotherapy, patients will be asked to return to the clinic 30 days after the last dose for a follow-up visit.
In both stages of the trial, patients record their cannabis medicine intake and experiences of nausea and vomiting for each chemotherapy cycle. These diaries are examined at the end of the trial to determine how effective the cannabis medicine and placebo were at controlling the nausea and vomiting.
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. Please contact your treating oncologist or palliative care specialist to discuss these eligibility criteria.
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.
- call the Help Line, 1800 217 257
- email the Centre for Medicinal Cannabis Research and Innovation, firstname.lastname@example.org
- write to Cannabis Trials, Centre for Medicinal Cannabis Research and Innovation, Locked Mail Bag 961, North Sydney, NSW 2059
For more information about cancer services in NSW, go to the Cancer Institute NSW website, www.cancerinstitute.org.au