A clinical trial has investigated the potential of Sativex, a cannabis-based medication, in treating glioblastoma multiforme, an aggressive form of brain cancer. The study’s aim was to determine if combining Sativex with chemotherapy can extend the lives of patients with recurrent glioblastoma. Initial results are encouraging, and researchers hope that Sativex could become a new treatment option.
Glioblastoma – Is Medical Cannabis the Future of Brain Cancer Treatment?
The beginning of 2023 brings new hope for patients with the most aggressive brain tumors in the United Kingdom. The first clinical trials have begun to investigate the effectiveness of Sativex, a cannabis-based medication, in the treatment of glioblastoma multiforme.
The ARISTOCRAT study, conducted at Leeds Teaching Hospitals NHS Trust and Christie NHS Foundation Trust in Manchester, is a pioneering global initiative. Its aim is to examine whether combining Nabiximols (also known as Sativex) with chemotherapy can contribute to prolonging the lives of individuals suffering from recurrent glioblastoma multiforme.
Scientific and Community Mobilization
The study, led by scientists from the University of Leeds and the Cancer Research UK unit at the University of Birmingham, plans to involve over 230 patients with glioblastoma multiforme from 14 NHS hospitals in England, Scotland, and Wales. This is made possible through a fundraising campaign conducted by The Brain Tumour Charity, which, with the support of Olympian Tom Daley, managed to raise the necessary £450,000.
The Challenging Battle Against Glioblastoma
Glioblastoma multiforme is the most aggressive form of brain cancer, with an average survival time of less than ten months after disease recurrence. Currently, according to The Brain Tumour Charity, therapeutic options for individuals with recurrent glioblastoma multiforme are very limited.
Phase I studies conducted in 2021 on 27 patients showed that Nabiximols can be tolerated by patients in combination with chemotherapy and, more importantly, have the potential to extend the lives of individuals with recurrent glioblastoma multiforme. If the Phase II studies confirm these results, experts hope that Sativex could become a new tool for brain tumor patients, the first since the introduction of temozolomide chemotherapy in 2007.
What Is Sativex?
Sativex is a prescription medication intended for the treatment of moderate to severe muscle spasticity in individuals with multiple sclerosis. It is delivered as an oral spray, with a package containing three bottles of 10 ml each.
The formula of Sativex contains two cannabinoids isolated from the flowers of Cannabis sativa – delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Their action focuses on cannabinoid receptors CB1 and CB2, which are mainly distributed in nerve endings. This may affect the function of neurotransmitters, alleviate muscle spasticity, and improve mobility. After the application of Sativex spray, the active ingredients are rapidly absorbed, and traces of them are detectable in the bloodstream as early as 15 minutes after application to the oral mucosa. The cannabinoids then distribute throughout the body, accumulating in fatty tissue.
In 1 ml of Sativex, there is 27 mg/ml of THC and 25 mg/ml of CBD. In every 100 microliters of the spray, there are 2.7 mg of THC and 2.5 mg of CBD. Additional ingredients include anhydrous ethanol, propylene glycol, and peppermint oil.
Great Hope for Glioblastoma Patients
Dr. David Jenkinson, the Chief Scientific Officer of The Brain Tumour Charity, emphasizes the tremendous significance of the research:
“We are very excited to start this groundbreaking study in the UK, which has the potential to accelerate the fight against this devastating disease. Over the past decade, patients and scientists have shown significant interest in the potential of cannabinoids in treating brain gliomas. We are very grateful to everyone worldwide who contributed to funding this important research.”
“The initial results are encouraging. We now eagerly await the answer to whether adding Nabiximols to chemotherapy can improve the quality of life and prolong the lives of individuals affected by the diagnosis of glioblastoma multiforme recurrence. We hope that this could be the first new drug for glioma treatment in over 15 years.”
Researchers aim to determine whether adding Sativex to the current standard chemotherapy (temozolomide) can provide patients with recurrent glioblastoma additional life expectancy.
Study participants are recommended to take up to 12 doses of Sativex or a placebo per day (or the maximum tolerated dose if lower than 12), administered orally. They will then be regularly monitored, including clinical assessments every four weeks, blood tests, MRI scans every eight weeks, and completion of quality of life questionnaires.
Is Medical Cannabis the Answer to Glioblastoma?
Professor Susan Short, the lead investigator of the study at the University of Leeds, comments:
“We are very excited about the opportunity to initiate this study here in Leeds. We look forward to conducting this study, which will show us whether cannabinoid-based drugs can help treat the most aggressive brain tumors. Treating gliomas is extremely challenging. Even after surgery, radiotherapy, and chemotherapy, almost all of these brain tumors regrow within a year. Unfortunately, when this happens, options for patients are very limited.”
Caution Regarding Cannabis-Based Therapy
The potential of cannabis in the treatment and even prevention of certain types of cancer is an area of research that is rapidly developing. Cannabis-based products, both in anecdotes and an increasing number of scientific studies, have shown to be helpful to patients in various ways, whether in managing palliative pain or reducing the side effects of standard therapies such as chemotherapy.
However, there is currently no solid evidence for the effectiveness of cannabis in treating brain tumors.
As Dr. Jenkinson emphasizes: “Currently, although some cannabinoid-based products may help alleviate symptoms, there is not enough evidence to recommend their use in treating brain tumors. If you are considering the use of cannabinoid-based products or other complementary therapies, it is crucial to first discuss this with your medical team, as they may affect other treatment methods, such as antiepileptic drugs or steroids.”
Cannabis in the Fight Against the Most Aggressive Form of Brain Cancer
Cannabinoid-based medications have well-described effects on the brain, and their application in various types of cancer has long been of great interest. Glioblastoma multiforme has cannabinoid receptors on the surface of its cells. Laboratory studies on glioma cells have shown that these medications can slow tumor growth and are particularly effective when used in conjunction with temozolomide.
“We now have the opportunity to build on these laboratory findings and the Phase I clinical trial results to investigate whether this drug can help glioblastoma patients live longer in the context of this randomized clinical trial, the first of its kind,” emphasizes Professor Short.
This study is particularly important because it could bring a breakthrough in the treatment of one of the most deadly forms of cancer. With current treatments, the survival rate of glioma patients after a relapse is less than ten months. Sativex could prove to be a valuable tool in the fight against this disease, offering patients hope for a longer and better life.
(Featured image by David Matos via Unsplash)
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