Evidence map›Paper›PMID 30209152›Full record

ArticleBMJ open2018

Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV).

Antony J Mersiades, Annette Tognela, Paul S Haber, Martin Stockler, Nicholas Lintzeris, John Simes, Iain McGregor, Ian Olver, David J Allsop, Craig Gedye and 10 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–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.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. In the weeds: a retrospective study of patient interest in and experience with cannabis at a cancer center.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Prescribing medicinal cannabis.Australian prescriber · 2020
    Review
  13. Review
  14. The use of cannabis for Hyperemesis Gravidarum (HG).Journal of cannabis research · 2020
    Article
  15. Review
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

20 authors.

Antony J MersiadesNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Annette TognelaMacarthur Cancer Therapy Centre, Campbelltown Hospital, Sydney, New South Wales, Australia.
Paul S HaberDiscipline of Addiction Medicine, University of Sydney, Sydney, New South Wales, Australia.
Martin StocklerNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Nicholas LintzerisDiscipline of Addiction Medicine, University of Sydney, Sydney, New South Wales, Australia.
John SimesNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Iain McGregorLambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, New South Wales, Australia.
Ian OlverUniversity of South Australia Cancer Research Institute, University of South Australia, Adelaide, South Australia, Australia.
David J AllsopLambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, New South Wales, Australia.
Craig GedyeDepartment of Medical Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
Adrienne C KirbyNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Rachael L MortonNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Peter FoxCentral West Cancer Care Centre, Orange Health Service, Orange, New South Wales, Australia.
Stephen ClarkeDepartment of Medical Oncology, Royal North Shore Hospital, Sydney, New South Wales, Australia.
Karen BriscoeMid North Coast Cancer Institute, Coffs Harbour Hospital, Coffs Harbour, New South Wales, Australia.
Morteza AghmeshehIllawarra Shoalhaven Cancer and Haematology Network, Wollongong Hospital, Wollongong, New South Wales, Australia.
Nicole WongNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Anna WalshNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Carmel HahnDepartment of Medical Oncology, Chris O'Brien Lifehouse, Sydney, New South Wales, Australia.
Peter GrimisonNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChemotherapy-induced nausea and vomiting (CINV) remains an important issue for patients receiving chemotherapy despite guideline-consistent antiemetic therapy. Trials using delta-9-tetrahydrocannabinol-rich (THC) products demonstrate limited antiemetic effect, significant adverse events and flawed study design. Trials using cannabidiol-rich (CBD) products demonstrate improved efficacy and psychological adverse event profile. No definitive trials have been conducted to support the use of cannabinoids for this indication, nor has the potential economic impact of incorporating such regimens into the Australian healthcare system been established. CannabisCINV aims to assess the efficacy, safety and cost-effectiveness of adding TN-TC11M, an oral THC/CBD extract to guideline-consistent antiemetics in the secondary prevention of CINV. METHODS AND ANALYSIS: The current multicentre, 1:1 randomised cross-over, placebo-controlled pilot study will recruit 80 adult patients with any malignancy, experiencing CINV during moderate to highly emetogenic chemotherapy despite guideline-consistent antiemetics. Patients receive oral TN-TC11M (THC 2.5mg/CBD 2.5 mg) capsules or placebo capsules three times a day on day -1 to day 5 of cycle A of chemotherapy, followed by the alternative drug regimen during cycle B of chemotherapy and the preferred drug regimen during cycle C. The primary endpoint is the proportion of subjects attaining a complete response to CINV. Secondary and tertiary endpoints include regimen tolerability, impact on quality of life and health system resource use. The primary assessment tool is patient diaries, which are filled from day -1 to day 5. A subsequent randomised placebo-controlled parallel phase III trial will recruit a further 250 patients. ETHICS AND DISSEMINATION: The protocol was approved by ethics review committees for all participating sites. Results will be disseminated in peer-reviewed journals and at scientific conferences. DRUG SUPPLY: Tilray. PROTOCOL VERSION: 2.0, 9 June 2017. TRIAL REGISTRATION NUMBER: ANZCTR12616001036404; Pre-results.

Indexed as

PhytotherapySecondary PreventionAdministration, OralAntineoplastic AgentsCannabidiolCannabinoid Receptor AgonistsCost-Benefit AnalysisDouble-Blind MethodDronabinolDrug CombinationsHumansMulticenter Studies as TopicNauseaPatient Reported Outcome MeasuresPilot ProjectsRandomized Controlled Trials as TopicAntineoplastic AgentsCannabidiolCannabinoid Receptor AgonistsDronabinolDrug CombinationsTN-TC11Mantiemeticcannabidiolcannabischemotherapy-induced nausea and vomitingrandomized trial

Identifiers

PMID30209152
PMCPMC6144412

What OpenQuestion holds

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Registered trials

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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.