A world-first clinical trial led by UNSW to assess whether medicinal cannabis can enhance the quality of life for patients with advanced cancer will enrol its first patients in the coming months.
The trial, announced by NSW Premier Mike Baird and Minister for Medical Research Pru Goward last year, will be conducted by a research team led by UNSW Conjoint Associate Professor Meera Agar, from the South Western Sydney Clinical School.
Associate Professor Agar told a media briefing yesterday the trial is a ‘world first’, with few other trials having explored the effectiveness and safety of vaporised botanical cannabis.
“Previous clinical trials using vaporised botanical cannabis were very small and only studied the effect in chronic pain patients,” said Associate Professor Agar, who is also Clinical Trials Director with the Liverpool-based Ingham Institute.
“In our trial, patients will be using a vaporiser, which aims to maximise the delivery of therapeutic levels of THC before patients consume a meal, and to minimise the side effects in the intervening period between meals.” Associate Professor Agar
Up to 90% of people with advanced cancer will lose their appetite, with few treatment options currently available other than steroids, which are suboptimal.
Scientists are still working to understand the role that cannabis’ active ingredient —tetrahydrocannabinol (THC) plays in stimulating appetite.
A study published in Nature Neuroscience in 2014, as reported in Smithsonianmag.com, found that in mice, THC fits into receptors in the brain’s olfactory bulb, significantly increasing the animals’ ability to smell food and leading them to eat more of it. THC is one of at least 113 active cannabinoids identified in the cannabis plant.
The trial led Associate Professor Agar will examine whether vaporised botanical cannabis, rather than only specific or single cannabinoids, can improve appetite and alleviate other distressing symptoms including fatigue, altered taste and smell for food, low mood, weight loss, nausea, insomnia and pain.
Since the trial was announced, researchers have been working to obtain a legally produced, standardised product from a country that is able to export to Australia while the local industry is awaiting the Commonwealth’s licensing scheme to commence.
Researchers are importing a leaf product, Bedrobinol, produced in The Netherlands. The product is made using dried flower tips harvested from the female cannabis plants and is characterised by a 13.5% THC content.
A standardised product is important to ensure the delivery of a consistent and known dose that is free from contaminants.
“A standardised product is important to ensure the delivery of a consistent and known dose that is free from contaminants,” Professor Agar said.
“We know cannabis grown in different conditions can have vastly different concentrations of the various cannabinoids proposed to be mediating the medicinal effects. That is why standardisation of the product is so important.”
The trial will be undertaken in two parts. The first, known as a Phase 2 study, will enrol 30 patients from the Calvary Mater Newcastle Hospital and the Sacred Heart Health Service in Sydney. Patients with advanced cancer recruited into the trial will receive different doses of the vaporised botanical cannabis throughout a seven-day stay in hospital.
The second part of the trial, known as a Phase 3 study, will be informed by the results of Phase 2 and will enrol a larger number of patients in a number of major hospitals across NSW.