UK moves ahead with clinical trials of Sativex in brain tumor patients

A large-scale trial in the UK, the world's first according to the The Guardian, will examine whether Sativex oral cannabis spray can prolong the lives of patients with glioblastoma, an aggressive form of brain tumor. This second phase of the study involves 15 NHS (British National Health Service) hospitals across the country and is scheduled to start early next year.

The University of Leeds, responsible for the study, concluded, in the first phase, that the use of Sativex, an oral spray that contains THC and CBD, in conjunction with chemotherapy, can prolong the life of patients with glioblastomas, severe brain tumors, with a reduced survival rate. The average life expectancy after diagnosis is 10 months, and only 5% reach five years of survival.

How will it work?

The institution responsible for funding the study, Brain Tumor Charity, will recruit around 230 patients from 15 English hospitals and clinics. Two-thirds will receive Sativex in conjunction with chemotherapy and one-third will receive chemotherapy and placebo. This new study is being coordinated by the clinical trials unit of Cancer Research UK, at the University of Birmingham.

Susan Short, the study's principal investigator and Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds, told CannabisHealth that "gliomas have been shown to have receptors for cannabinoids on their cell surfaces and laboratory studies of glioma cells have shown that these substances can slow tumor growth and work particularly well when used with temozolomide [an active ingredient in chemotherapy]."

The conclusions of the first phase of the study, which involved 27 patients, were published in February this year in Nature. The main objective was to find out if it was safe to administer Sativex together with temozolomide, a drug used in chemotherapy.

This is not the first time that the results of cannabinoids in brain tumors have been tested. Ethan Russo e Manuel Guzman, who were in Portugal as speakers from the conference PTMC – Portugal Medical Cannabis, had already described the potential of cannabinoids in gliomas, among other pathologies.

The main side effects of the first phase of the trial were vomiting, dizziness, nausea, fatigue and headache. In terms of lifespan, 83% of subjects using Sativex lived an additional year, as did 44% of those in the placebo group. Two patients who were on placebo died within the first 40 days of the trial.

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