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dc.contributor.authorGrimison, P
dc.contributor.authorMersiades, A
dc.contributor.authorKirby, A
dc.contributor.authorLintzeris, N
dc.contributor.authorMorton, R
dc.contributor.authorHaber, P
dc.contributor.authorOlver, I
dc.contributor.authorWalsh, A
dc.contributor.authorMcGregor, I
dc.contributor.authorCheung, Y
dc.contributor.authorTognela, A
dc.contributor.authorHahn, C
dc.contributor.authorBriscoe, K
dc.contributor.authorAbdi, E
dc.contributor.authoret al.
dc.date.accessioned2021-02-11T23:58:43Z
dc.date.available2021-02-11T23:58:43Z
dc.date.issued2020
dc.identifier.issn0923-7534
dc.identifier.doi10.1016/j.annonc.2020.07.020
dc.identifier.urihttp://hdl.handle.net/10072/402029
dc.description.abstractBackground: 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.
dc.description.peerreviewedYes
dc.languageeng
dc.publisherElsevier BV
dc.relation.ispartofpagefrom1553
dc.relation.ispartofpageto1560
dc.relation.ispartofissue11
dc.relation.ispartofjournalAnnals of Oncology
dc.relation.ispartofvolume31
dc.subject.fieldofresearchOncology and carcinogenesis
dc.subject.fieldofresearchcode3211
dc.subject.keywordsantiemetic
dc.subject.keywordscannabidiol
dc.subject.keywordscannabis
dc.subject.keywordschemotherapy-induced nausea and vomiting
dc.subject.keywordsrandomised trial
dc.titleOral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationGrimison, 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; Abdi, E; et al., Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial, Annals of Oncology, 2020, 31 (11), pp. 1553-1560
dcterms.dateAccepted2020-07-27
dc.date.updated2021-02-11T23:56:23Z
gro.hasfulltextNo Full Text
gro.griffith.authorAbdi, Ehtesham


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