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Cited by 162Nausea and vomiting managementCannabis and Cannabinoid ResearchCancer survivorship and care

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Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial

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Grimison, P., Mersiades, A., Kirby, A., Lintzeris, N., Morton, R., Haber, P., Olver, I., Walsh, A., McGregor, I., Cheung, Y., Tognela, A., Hahn, C., Briscoe, K., Aghmesheh, M., Fox, P., Abdi, E., Clarke, S., Della-Fiorentina, S., Shannon, J., Gedye, C., Begbie, S., Simes, J., Stockler, M.·2020·Annals of Oncology
DOI 10.1016/j.annonc.2020.07.020
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Abstract

Background This multicentre, randomised, double-blinded, placebo-controlled, phase II/III trial aimed to evaluate an oral THC:CBD (tetrahydrocannabinol:cannabidiol) cannabis extract for prevention of refractory chemotherapy-induced nausea and vomiting (CINV). Here we report the phase II component results. Patients and methods Eligible patients experienced CINV during moderate-to-high emetogenic intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Study treatment consisted of one cycle of 1-4 self-titrated capsules of oral THC 2.5 mg/CBD 2.5 mg (TN-TC11M) three times daily, from days -1 to 5, and 1 cycle of matching placebo in a crossover design, then blinded patient preference for a third cycle. The primary end point was the proportion of participants with complete response during 0-120 h from chemotherapy. A total of 80 participants provided 80% power to detect a 20% absolute improvement with a two-sided P value of 0.1. Results A total of 81 participants were randomised; 72 completing two cycles were included in the efficacy analyses and 78 not withdrawing consent were included in safety analyses. Median age was 55 years (range 29-80 years); 78% were female. Complete response was improved with THC:CBD from 14% to 25% (relative risk 1.77, 90% confidence interval 1.12-2.79, P = 0.041), with similar effects on absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE). Thirty-one percent experienced moderate or severe cannabinoid-related adverse events such as sedation, dizziness, or disorientation, but 83% of participants preferred cannabis to placebo. No serious adverse events were attributed to THC:CBD. Conclusion The addition of oral THC:CBD to standard antiemetics was associated with less nausea and vomiting but additional side-effects. Most participants preferred THC:CBD to placebo. Based on these promising results, we plan to recruit an additional 170 participants to complete accrual for the definitive, phase III, parallel group analysis. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12616001036404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370473&isReview=true.

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Research works printed but not linked: 16

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Metadata

Authors
Grimison, P., Mersiades, A., Kirby, A., Lintzeris, N., Morton, R., Haber, P., Olver, I., Walsh, A., McGregor, I., Cheung, Y., Tognela, A., Hahn, C., Briscoe, K., Aghmesheh, M., Fox, P., Abdi, E., Clarke, S., Della-Fiorentina, S., Shannon, J., Gedye, C., Begbie, S., Simes, J., & Stockler, M.
Affiliations
  • Chris O’Brien Lifehouse (AU)
  • National Health and Medical Research Council (AU)
  • South Eastern Sydney Local Health District (AU)
  • The University of Sydney (AU)
  • The University of Adelaide (AU)
  • Camden and Campbelltown Hospitals (AU)
  • Wollongong Hospital (AU)
  • Northern Cancer Institute (AU)
  • Nepean Hospital (AU)
  • Calvary Mater Newcastle Hospital (AU)
Corresponding author
Grimison, P.
ORCID
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2020-11
Volume
31
Issue
11
Pages
1553-1560
ISSN
0923-7534 (ISSN-L)
DOI
10.1016/j.annonc.2020.07.020
OpenAlex
W3048881461
Cited by
162
References
0
Citations by year
2026: 16 · 2025: 26 · 2024: 42 · 2023: 26 · 2022: 40 · 2021: 11 · 2020: 1
FWCI
17.86
Type
journal article
Language
en
Open access
Licence
Locations
  • Annals of Oncology (publishedVersion)
  • PubMed (publishedVersion)
  • Griffith Research Online (submittedVersion, other-oa)
Funders
NSW Ministry of Health
Topics
  • Health Sciences › Medicine › Surgery › Nausea and vomiting management
  • Health Sciences › Medicine › Pharmacology (medical) › Cannabis and Cannabinoid Research
  • Health Sciences › Medicine › Oncology › Cancer survivorship and care
Keywords
tetrahydrocannabinol, cannabidiol, chemotherapy-induced nausea and vomiting, antiemetic prophylaxis, emesis prevention, patient preferences, Functional Living Index-Emesis, emetogenic chemotherapy, crossover trial
MeSH terms
Adult, Aged, Aged, 80 and over, Antiemetics, Antineoplastic Agents, Australia, Cannabidiol, Cannabis, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Nausea, Plant Extracts, Dronabinol, Vomiting, Cross-Over Studies

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