A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas

Schloss, J; Lacey, J; Sinclair, J; Steel, A; Sughrue, M; Sibbritt, D; Teo, C

A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas

Schloss, J

Lacey, J Sinclair, J Steel, A

Sughrue, M Sibbritt, D

Teo, C

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Publisher:: Frontiers Media
Publication Type:: Journal Article
Citation:: Frontiers in Oncology, 2021, 11
Issue Date:: 2021-05-21

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Field	Value	Language
dc.contributor.author	Schloss, J https://orcid.org/0000-0003-1643-6215
dc.contributor.author	Lacey, J
dc.contributor.author	Sinclair, J
dc.contributor.author	Steel, A https://orcid.org/0000-0001-6643-9444
dc.contributor.author	Sughrue, M
dc.contributor.author	Sibbritt, D https://orcid.org/0000-0003-3561-9447
dc.contributor.author	Teo, C
dc.date.accessioned	2021-09-06T01:18:27Z
dc.date.available	2021-04-22
dc.date.available	2021-09-06T01:18:27Z
dc.date.issued	2021-05-21
dc.identifier.citation	Frontiers in Oncology, 2021, 11
dc.identifier.issn	2234-943X
dc.identifier.issn	2234-943X
dc.identifier.uri	http://hdl.handle.net/10453/150341
dc.description.abstract	<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.<h4>Clinical trial registration</h4>Australian New Zealand Clinical Trials Registry (ANZCTR) http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373556&isReview=true, identifier ACTRN12617001287325.
dc.format	Electronic-eCollection
dc.language	eng
dc.publisher	Frontiers Media
dc.relation.ispartof	Frontiers in Oncology
dc.relation.isbasedon	10.3389/fonc.2021.649555
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1112 Oncology and Carcinogenesis
dc.title	A Phase 2 Randomised Clinical Trial Assessing the Tolerability of Two Different Ratios of Medicinal Cannabis in Patients With High Grade Gliomas
dc.type	Journal Article
utslib.citation.volume	11
utslib.location.activity	Switzerland
utslib.for	1112 Oncology and Carcinogenesis
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Public Health
utslib.copyright.status	open_access	*
pubs.consider-herdc	false
dc.date.updated	2021-09-06T01:18:23Z
pubs.publication-status	Published
pubs.volume	11

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.

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http://hdl.handle.net/10453/150341