A nightly dose of medicinal cannabis (MC) improved sleep and other quality of life (QOL) outcomes in patients with high-grade gliomas, according to results of a study published in Frontiers in Oncology.
Researchers conducted a randomized, phase 2 trial comparing 2 ratios of oral MC oil in patients diagnosed with recurrent or inoperable high-grade gliomas, including glioblastoma multiforme and grade III anaplastic astrocytoma.
The study enrolled 88 patients. Their average age was 53.3 years, a majority of patients were White (95.2%), and about half were women (49.4%).
Patients were randomly assigned to receive a 1:1 ratio of delta-9-tetrahydrocannabinol (THC) to cannabidiol (CBD) or a 4:1 ratio of THC to CBD. In the 1:1 group, the dose of THC was 4.6 mg/ml, and the CBD dose was 4.8 mg/ml. In the 4:1 group, the THC dose was 15 mg/ml, and the CBD dose was 3.8 mg/ml.
The researchers assessed QOL changes from baseline to week 12 using a paired t-test for the Functional Assessment of Cancer Therapy – Brain (FACT-Br). The results showed greater improvements in physical domains (P =.025), functional domains (P =.014), and sleep (P =.009) with the 1:1 ratio over the 4:1 ratio.
The researchers also assessed disease status via MRI. There were 53 patients who underwent MRI at baseline and week 12.
The scans showed no significant differences in disease status between the 1:1 and 4:1 treatment arms. Overall, 11% of patients had a reduction in disease, 34% had stable disease, 16% had a T2 flair and slight enhancement, and 10% had progressive disease.
Both MC ratios were well-tolerated, according to the researchers. There were no serious adverse events in either arm. The most common side effects were dry mouth (13%), tiredness at night (11%), dizziness mainly at night (10%), and drowsiness (7%).
“[T]his study is one of the first to evaluate the safety and tolerability of MC in this vulnerable cancer population, a patient group with BBB [blood-brain barrier] disruption, impaired brain function, and numerous medications, including chemotherapy, corticosteroids, and antiepileptics,” the researchers wrote.
“Our study data suggest that cannabis, especially a 1:1 CBD/THC mixture, can be helpful for many of the symptoms impacting QOL in this patient population, especially sleep disturbance.”
Disclosures: This research was supported by FIT-Bioceuticals Pty Ltd. The study authors declared no conflicts of interest.
Schloss J, Lacey J, Sinclair J, et al. A phase 2 randomised clinical trial assessing the tolerability of two different ratios of medicinal cannabis in patients with high grade gliomas. Front Oncol. Published online May 21, 2021. doi:10.3389/fonc.2021.649555