A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Whole Plant Extracts of Cannabis in Cancer

Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With Cancer – High Grade Gliomas

A randomized trial involving adult patients diagnosed with a high-grade glioma, no history of substance abuse, liver or kidney damage or myocardial infarction were eligible for inclusion in a tolerability study on two different ratios of medicinal cannabis.

Participants were on average 53.3 years old. 

 • from baseline to week 12 found that the 1:1 ratio favoured both physical (p=0.025) and functional (p=0.014) capacity and improved sleep (p=0.009).

•  Analysis of changes from baseline to week 12 also found ;

11% of 61 participants had a reduction in disease

 34% were stable 

16% had slight enhancement 

10% had progressive disease. 

No serious adverse events occurred. Side effects included dry mouth, tiredness at night, dizziness, drowsiness.

 The investigational product consisted of two standardised and quality-assured specially formulated oil-based organic WHOLE PLANT EXTRACTS of CANNABIS based on :

1:1  THC 4.6mg/ml:CBD 4.8mg/ml 

4:1  THC 15mg/ml:CBD 3.8mg/ml  

This study demonstrated that a single nightly dose of THC-containing medicinal cannabis was safe, had no serious adverse effects and was well tolerated in patients. Medicinal cannabis significantly improved sleep, functional wellbeing, and quality of life.

Frontiers | A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas (frontiersin.org)

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