Evidence map›Paper›PMID 39151115›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Oral Cannabis Extract for Secondary Prevention of Chemotherapy-Induced Nausea and Vomiting: Final Results of a Randomized, Placebo-Controlled, Phase II/III Trial.

Peter Grimison, Antony Mersiades, Adrienne Kirby, Annette Tognela, Ian Olver, Rachael L Morton, Paul Haber, Anna Walsh, Yvonne Lee, Ehtesham Abdi and 14 more

Abstract readClinical Trial, Phase IIRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Efficacy of cannabinoids for the prophylaxis of chemotherapy-induced nausea and vomiting-a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  3. Cannabis and Cannabinoids in Adults With Cancer: ASCO Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Guideline
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Peter GrimisonChris O'Brien Lifehouse, Sydney, NSW, Australia.ORCID 0000-0002-2653-1657
Antony MersiadesNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Adrienne KirbyNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Annette TognelaMacarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown, NSW, Australia.ORCID 0000-0003-0875-4352
Ian OlverUniversity of Adelaide, Adelaide, SA, Australia.ORCID 0000-0001-5478-1576
Rachael L MortonNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0001-7834-0572
Paul HaberRoyal Prince Alfred Hospital, Sydney, NSW, Australia.
Anna WalshNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0002-8920-248X
Yvonne LeeNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0002-2422-9198
Ehtesham AbdiThe Tweed Hospital, Tweed Heads, NSW, Australia.
Stephen Della-FiorentinaSouthern Highlands Cancer Centre, Bowral, NSW, Australia.
Morteza AghmeshehDepartment of Medical Oncology, Wollongong Hospital, Wollongong, NSW, Australia.
Peter FoxDept of Medical Oncology, Orange Base Hospital, Orange, NSW, Australia.
Karen BriscoeDepartment of Medical Oncology, Coffs Harbour Hospital, Coffs Harbour, NSW, Australia.ORCID 0000-0002-1491-6920
Jasotha SanmugarajahDepartment of Medical Oncology, Gold Coast University Hospital, Gold Coast, QLD, Australia.
Gavin MarxDepartment of Medical Oncology, Sydney Adventist Hospital, Wahroonga, NSW, Australia.ORCID 0000-0002-1016-6544
Ganessan KichenadasseDepartment of Medical Oncology, Flinders Medical Centre, Adelaide, NSW, Australia.ORCID 0000-0001-9923-5149
Helen WheelerDepartment of Medical Oncology, Royal North Shore Hospital, Gosford, NSW, Australia.
Matthew ChanDepartment of Medical Oncology, Gosford Hospital, Gosford, NSW, Australia.ORCID 0000-0001-6759-6935
Jenny ShannonDepartment of Medical Oncology, Nepean Hospital, Kingswood, NSW, Australia.
Craig GedyeDepartment of Medical Oncology, Calvary Mater Hospital, Newcastle, NSW, Australia.ORCID 0000-0002-1629-4352
Stephen BegbieDepartment of Medical Oncology, Port Macquarie Hospital, Port Macquarie, NSW, Australia.ORCID 0000-0001-9277-6479
R John SimesNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Martin R StocklerNHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0003-3793-8724

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of this randomized, placebo-controlled, two-stage, phase II/III trial was to determine the efficacy of an oral cannabis extract in adults with refractory nausea and/or vomiting during moderately or highly emetogenic, intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Here, we report results of the prespecified combined analysis including the initial phase II and subsequent phase III components. PATIENTS AND

methodsStudy treatment consisted of oral capsules containing either tetrahydrocannabinol 2.5 mg plus cannabidiol 2.5 mg capsules (THC:CBD) or matching placebo, taken three times a day from days -1 to 5, in addition to guideline-consistent antiemetics. The primary measure of effect was the difference in the proportions of participants with no vomiting or retching and no use of rescue medications (a complete response) during hours 0-120 after the first cycle of chemotherapy on study (cycle A).

resultsWe recruited 147 evaluable of a planned 250 participants from 2016 to 2022. Background antiemetic prophylaxis included a corticosteroid and 5-hydroxytryptamine antagonist in 97%, a neurokinin-1 antagonist in 80%, and olanzapine in 10%. THC:CBD compared with placebo improved the complete response rate from 8% to 24% (absolute difference 16%, 95% CI, 4 to 28,

conclusionTHC:CBD is an effective adjunct for chemotherapy-induced nausea and vomiting despite standard antiemetic prophylaxis, but was associated with additional adverse events. Drug availability, cultural attitudes, legal status, and preferences may affect implementation. Future analyses will evaluate the cost-effectiveness of THC:CBD.

Indexed as

AntiemeticsCannabidiolDronabinolNauseaPlant ExtractsVomitingAdministration, OralAdultAgedAntineoplastic AgentsCannabisDouble-Blind MethodFemaleHumansMaleMiddle AgedAntiemeticsAntineoplastic AgentsCannabidiolDronabinolPlant Extracts

Identifiers

PMID39151115
PMCPMC11608591

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.