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Published (Version of record)CC BY V4.0, Open Access
Published (Version of record)CC BY V4.0, Open
Journal article
A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas
Frontiers in Oncology, Vol.11, pp.1-13
21/05/2021
PMID: 34094937
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Source: InCites
Abstract
Background: Cannabis for cancer is very topical and, given the use of illicit cannabis preparations used in this vulnerable population, research investigating standardised, quality-assured medicinal cannabis is critical to inform clinicians and assist patient safety.
Methods: 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. Baseline screening of brain morphology, blood pathology, functional status, and cognition was conducted. A retrospective control group was used for comparison for secondary outcomes.
Results: Participants (n=88) were on average 53.3 years old. A paired t-test assessed the Functional Assessment of Cancer Therapy for Brain Cancer (FACT-Br) between groups 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, and 10% had progressive disease. No serious adverse events occurred. Side effects included dry mouth, tiredness at night, dizziness, drowsiness.
Conclusion: 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.
Clinical Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373556&isReview=true, identifier ACTRN12617001287325.
Details
- Title
- A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas
- Creators
- Janet Schloss - Southern Cross UniversityJudith Lacey - Western Sydney UniversityJustin Sinclair - Western Sydney UniversityAmie Steel - University of Technology SydneyMichael Sughrue - Prince of Wales HospitalDavid Sibbritt - University of Technology SydneyCharles Teo - Prince of Wales Hospital
- Publication Details
- Frontiers in Oncology, Vol.11, pp.1-13
- Publisher
- Frontiers Research Foundation
- Grant note
- This study was supported financially by FIT-Bioceuticals Pty Ltd, Sydney, Australia. The funder bodies were not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.
- Identifiers
- 991012948482102368
- Copyright
- Copyright © 2021 Schloss, Lacey, Sinclair, Steel, Sughrue, Sibbritt and Teo. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
- Academic Unit
- School of Health and Human Sciences; National Centre for Naturopathic Medicine; Faculty of Health
- Language
- English
- Resource Type
- Journal article