QUT has received nearly $ 700,000 from the Medical Research Future Fund (MRFF) to assess the effectiveness, safe dosing and side effects of two medicinal cannabis products for managing symptoms in children with advanced cancer.
The three-year trial is expected to commence this year and will be led by QUT Adjunct Associate Professor Anthony Herbert, who is also Director of Children’s Health Queensland’s Pediatric Palliative Care Service.
“We want to investigate whether giving medical cannabis to children receiving palliative care for advanced cancer improves their symptoms such as pain and sleep,” said associate professor Herbert.
“This group of children may not have long to live, so their quality of life is very important, and we want to know if this intervention can help them in their final weeks or months of life.
“This study will add to the limited evidence on the role and safe use of medical cannabis in children, which can be used to inform future clinical trials.
“In Australia, this will be the first study in children using medical cannabis to manage symptoms in children with cancer receiving palliative care. No comparable studies have been published in the worldwide literature. “
The trial will compare different combinations and ratios of cannabidiol (CBD) and tetrahydrocannabinol (THC) to determine which one is preferred in reducing symptoms.
Researchers measure symptom scores for appetite, lack of energy, pain, sleepiness, nausea, and vomiting. They will also measure sleep and activity using actigraphy, quality of life scores, as well as anxiety and depression scores.
“We will also look at the overall burden of symptoms, because treatment cannot significantly affect any symptom, but can help in general,” said associate professor Herbert.
“Reducing painkillers, measuring blood cannabinoid concentrations and other health-related biomarkers of inflammation will be part of the reviews.
Professor Murray Mitchell, of the QUT School of Biomedical Sciences is head of the Child and Reproductive Health group at the Center for Children’s Health Research and will coordinate the biomarker measurement and discovery arm of the study.
“We will measure blood levels of cannabis and related substances in order to ultimately optimize treatment schedules and potentially account for variations in treatment success,” said Professor Mitchell.
“The center is uniquely located at Queensland Children’s Hospital and is critical to the study as it brings together a wide range of experts to conduct the study and associated studies.”
Professor Murray Mitchell (front) and Assistant Professor Anthony Herbert.
Researchers will also ask patients, parents, and clinicians about their overall impression of the benefit of the treatment.
The clinical trial will be a win-win as patients will have access to the drug, but clinicians will also have the opportunity to observe the effects of medical cannabis in a structured and controlled manner to see if it has benefits without causing side effects such as drowsiness, or possibly even worsening of symptoms, ”said associate professor Herbert.
He said the trial could be affected by the relatively small number of children diagnosed with cancer needing palliative care.
Every year in Australia, about 770 children aged 0-14 years are diagnosed with cancer, and about 100 children under the age of 15 die from the disease.
In Queensland, about 30 children are referred to palliative care each year, so researchers will work with sites in Newcastle and Melbourne.
Associate professor Herbert said the study was exploratory in nature and not a definitive randomized controlled trial, due to its vulnerability and the small number of children involved.
The trial is expected to provide clinicians and researchers with more experience and research to guide practice and guide the feasibility of a larger, more definitive study for clinically or statistically significant differences between products.
Funding was part of the MRFF – Emerging Priorities and Consumer Driven Research – 2020 Medicinal Cannabis Clinical Trials Grant Opportunity to Support Clinical Trials Investigating the Effects of Medical Cannabis in Managing Pain, Symptoms and Side Effects of Cancer and Cancer Treatment in Cancer Patients .
The research is a collaboration between QUT, The University of Queensland, University of Sydney Children’s Health Queensland, Queensland Children’s Hospital, Royal Children’s Hospital in Melbourne. John Hunter Children’s Hospital, Newcastle and also Monash Medical Center, Melbourne.
Other QUT principal investigators include Associate Professor Natalie Bradford and Dr. Alison Bowers of the QUT Cancer and Palliative Care Outcomes Center.
Associate Professor Anthony Herbert, QUT and Children’s Health Queensland Professor Murray Mitchell, QUT Associate Professor Natalie Bradford, QUT Dr Alison Bowers, QUT Associate Professor Helen Heussler, The University of Queensland and Children’s Health Queensland Mr Michael Duhig, Children’s Health Queensland Professor Iain McGregor , University of Sydney Associate Professor Helen Heussler, Children’s Health Queensland Dr. Geoff Wallace, Children’s Health Queensland / University Release. This material comes from the original organization and may be point-in-time in nature, edited for clarity, style and length. View full here.