dc.contributor.author | Grimison, P | |
dc.contributor.author | Mersiades, A | |
dc.contributor.author | Kirby, A | |
dc.contributor.author | Lintzeris, N | |
dc.contributor.author | Morton, R | |
dc.contributor.author | Haber, P | |
dc.contributor.author | Olver, I | |
dc.contributor.author | Walsh, A | |
dc.contributor.author | McGregor, I | |
dc.contributor.author | Cheung, Y | |
dc.contributor.author | Tognela, A | |
dc.contributor.author | Hahn, C | |
dc.contributor.author | Briscoe, K | |
dc.contributor.author | Abdi, E | |
dc.contributor.author | et al. | |
dc.date.accessioned | 2021-02-11T23:58:43Z | |
dc.date.available | 2021-02-11T23:58:43Z | |
dc.date.issued | 2020 | |
dc.identifier.issn | 0923-7534 | |
dc.identifier.doi | 10.1016/j.annonc.2020.07.020 | |
dc.identifier.uri | http://hdl.handle.net/10072/402029 | |
dc.description.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. | |
dc.description.peerreviewed | Yes | |
dc.language | eng | |
dc.publisher | Elsevier BV | |
dc.relation.ispartofpagefrom | 1553 | |
dc.relation.ispartofpageto | 1560 | |
dc.relation.ispartofissue | 11 | |
dc.relation.ispartofjournal | Annals of Oncology | |
dc.relation.ispartofvolume | 31 | |
dc.subject.fieldofresearch | Oncology and carcinogenesis | |
dc.subject.fieldofresearchcode | 3211 | |
dc.subject.keywords | antiemetic | |
dc.subject.keywords | cannabidiol | |
dc.subject.keywords | cannabis | |
dc.subject.keywords | chemotherapy-induced nausea and vomiting | |
dc.subject.keywords | randomised trial | |
dc.title | Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial | |
dc.type | Journal article | |
dc.type.description | C1 - Articles | |
dcterms.bibliographicCitation | 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; 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.dateAccepted | 2020-07-27 | |
dc.date.updated | 2021-02-11T23:56:23Z | |
gro.hasfulltext | No Full Text | |
gro.griffith.author | Abdi, Ehtesham | |