The phase 2 trial will examine whether high THC medicinal cannabis* can be tolerated by people with glioma (a type of brain tumour) and if it can affect tumour growth when taken with standard treatment, according to lead researcher Dr Janet Schloss, the Clinical Trials Coordinator at Endeavour College of Natural Health. (*THC is the main psychoactive ingredient of cannabis)
“This will be the first clinical trial worldwide to examine tolerability and tumour effect from orally ingested medicinal cannabis in humans with cancer of any type,” Dr Schloss said.
“Our Endeavour College research team will collaborate with Professor Teo to examine the impact of medicinal cannabis when it is used alongside standard treatment for cancer.
“As well as tumour impact, we’ll be looking at whether medicinal cannabis can improve quality of life, by reducing common symptoms such as headache, nausea and vomiting.”
Dr Schloss said glioma is a particularly aggressive brain tumour that often proves resistant to surgery, chemotherapy and radiation.
“This resistance means it’s vital for researchers to develop new therapies to treat this disease, which is one of the reasons why the clinical trial is important,” she said.
“Recent studies have shown that the active agents in cannabis may slow tumour growth and we believe further research is essential. If we can establish dosage guidelines and understand whether medicinal cannabis can assist standard treatment, this could be life-changing for glioma patients and their families.” (see page 2 for glioma details)
Coming together for better patient outcomes
Professor Teo, a former Australian of the Year, will be an Associate Investigator for the trial and will lead patient recruitment through his clinic at the Prince of Wales Private Hospital.
“This is a great example of complementary medicine researchers working in conjunction with the medical fraternity to bring about better outcomes for our patients,” Professor Teo said.
The clinical trial is funded by BioCeuticals, Australia’s leading provider of nutritional and therapeutic supplements, who have invested more than $500,000 as part of their commitment to provide practitioners with evidence-based solutions for health conditions.
BioCeuticals Director of Research, Development and Emerging Markets, Belinda Reynolds, said: “There is increasing public, political and practitioner awareness of medicinal cannabis, and it’s important that we have credible research into any health benefits”.
About the world-first trial
The trial has ethics approval and NSW ministry of health approval. Endeavour’s research team will assess the suitability of volunteers from among Professor Teo’s patients and other glioma patients who meet the inclusion criteria. The team will then administer the liquid medicinal cannabis and coordinate MRI, blood and other testing.
Patients will continue to see Professor Teo, his colleague Dr Mike Sughrue, or their medical specialists for treatment during the trial, while being monitored by Dr Schloss’ team during the three months of taking medicinal cannabis. The team will then follow patients for up to two years after the trial.
While medicinal cannabis is classified as a medicine, it is actually a plant. The herbal medicine expertise of Endeavour’s Office of Research, and their experience leading robust empirical research, makes them ideally placed to bring this world-first trial to fruition.
The clinical trial aims to strengthen complementary medicine’s evidence-based research and explore how it can impact on patient care and outcomes.
Dr Schloss said she hoped the trial’s findings would be valuable in guiding policy change, given the growing public demand for safe, reliable and legal access to medicinal cannabis through authorised doctors.
• Glioma is the most common form of primary brain tumour and among the most malignant cancers, often not responding effectively to surgery, chemotherapy or radiation therapy.
• Median survival time is one year. Gliomas remain a major medical challenge due to the tumour’s location, aggressive behaviour, rapid growth and low survival rate.
• Treatment usually involves surgical removal of the bulk of the tumour, followed by radiation and chemotherapy. Prognosis for patients is bleak, with only half surviving for 15 months and less than 5% of patients still alive five years after diagnosis.
• Gliomas can affect any age group but are more common in older people (average age of diagnosis is 64). 1000 Australians are diagnosed each year.
• Common symptoms are memory and speech difficulties, weakness on one side of the body and changes to vision.
Lead researcher Dr Janet Schloss is Clinical Trials Coordinator at Endeavour College of Natural Health’s Office of Research. She has dedicated her career to supporting cancer patients and expanding the body of evidence-based research for complementary medicine and its ability to assist people undergoing chemotherapy and radiation. Dr Schloss has coordinated and conducted clinical trials for more than 8 years on a variety of research topics involving cancer, chemotherapy and chronic disease.
She has 19 years’ clinical experience in the field of oncology and complementary medicine, and collaborates with many oncologists around Australia. She also currently practices at the Mater Private Breast Cancer Centre and Body Organics, alongside medical and radiation oncologists, surgeons and related health professionals.
Endeavour College of Natural Health’s Office of Research is dedicated to strengthening professional practice for complementary medicine professionals through an expanded body of evidence-based research for complementary medicine in Australia. It works to disseminate and critically examine all aspects of contemporary complementary medicine practice through the application of non-partisan, rigorous, and robust empirical research. The Office of Research is an arm of Endeavour College of Natural Health, Australasia’s largest degree conferring tertiary institution offering qualifications in complementary medicine and natural health. It has six campuses in Australia and two in New Zealand, five Bachelor degrees, four Honours degrees, 5,000 students, 350 staff and leading academics in the field.