The Brain Tumour Charity has launched an appeal to fund a new three-year medical trial of a cannabis-based drug (Sativex) with chemotherapy treatment, in the hope that it will extend the lives of people with recurrent glioblastoma.
The condition, which is the most common and most aggressive form of brain cancer with around 2,200 people diagnosed each year in England alone, currently has an average survival of less than 10 months.
Sativex, a medical mouth spray that contains a mix of CBD and THC, was approved for use on the NHS in 2019 to treat muscle spasms linked to multiple sclerosis.
If the trial proves successful, they hope it could represent one of the first additions to NHS treatment for glioblastoma patients in more than a decade.
Tom Daley, legendary Olympic diver, featured in a video appealing for others "to help fund this groundbreaking trial".
The gold medal winner has been campaigning for The Brain Tumour Charity since the loss of his father in 2011. Daley recently raffled off a rainbow jumper hand-knit by himself, raising £5,787 for the charity in 14 days.
Over the last decade, there has been significant global interest within both patient and scientific communities about the activity of cannabinoids in brain tumours, with the view that cannabinoid-based products may not only help relieve symptoms but could also have a positive impact on survival.
Several pre-clinical laboratory studies have suggested that cannabinoids THC and CBD may reduce brain tumour cell growth and could disrupt the blood supply to tumours - however, to date, clinical evidence that they could treat brain tumours has been limited.
In this new phase II trial, researchers will assess whether adding Sativex to the current standard chemotherapy treatment (temozolomide) could offer extra time to live for adults diagnosed with a recurrence of their glioblastoma after initial treatment.
The trial plans to recruit 232 participants across a minimum of 15 hospitals: two thirds of the participants will be given temozolomide plus Sativex, while one third will be given temozolomide plus placebo.
Sativex is an oromucosal spray containing 1:1 THC (Delta-9-tetrahydrocannabinol) and CBD (cannabidiol), with the active ingredients being absorbed in the lining of the mouth, either under the tongue or inside the cheek.
Participants will be asked to administer up to 12 sprays per day (or to the maximum dose they can tolerate if fewer than 12) of Sativex or placebo oral sprays.
Participants will then undergo regular follow-up including clinical assessment (every four weeks), blood tests, MRI scans (every eight weeks), and they will complete quality of life questionnaires. This will also be one of the first trials to integrate with The Brain Tumour Charity’s app BRIAN.
The trial will measure whether adding Sativex to chemotherapy extends the overall length of patients’ lives (overall survival), delays the progression of their disease (progression-free survival) or improves quality of life.
