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  • 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)

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Oncology
Protocol
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)
  1. Antony J Mersiades1,
  2. Annette Tognela2,
  3. Paul S Haber3,4,
  4. Martin Stockler1,5,
  5. Nicholas Lintzeris3,6,
  6. John Simes1,7,
  7. Iain McGregor8,
  8. Ian Olver9,
  9. David J Allsop8,
  10. Craig Gedye10,
  11. Adrienne C Kirby1,
  12. Rachael L Morton1,
  13. Peter Fox11,
  14. Stephen Clarke12,13,
  15. Karen Briscoe14,
  16. Morteza Aghmesheh15,
  17. Nicole Wong1,
  18. Anna Walsh1,
  19. Carmel Hahn7,
  20. Peter Grimison1,7
  1. 1 NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia
  2. 2 Macarthur Cancer Therapy Centre, Campbelltown Hospital, Sydney, New South Wales, Australia
  3. 3 Discipline of Addiction Medicine, University of Sydney, Sydney, New South Wales, Australia
  4. 4 Drug Health Services, Sydney Local Health District, Sydney, New South Wales, Australia
  5. 5 Department of Medical Oncology, Concord Cancer Care Centre, Concord Hospital, Sydney, New South Wales, Australia
  6. 6 Drug and Alcohol Services, South East Sydney Local Health District, Sydney, New South Wales, Australia
  7. 7 Department of Medical Oncology, Chris O’Brien Lifehouse, Sydney, New South Wales, Australia
  8. 8 Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Sydney, New South Wales, Australia
  9. 9 University of South Australia Cancer Research Institute, University of South Australia, Adelaide, South Australia, Australia
  10. 10 Department of Medical Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia
  11. 11 Central West Cancer Care Centre, Orange Health Service, Orange, New South Wales, Australia
  12. 12 Department of Medical Oncology, Royal North Shore Hospital, Sydney, New South Wales, Australia
  13. 13 Bill Walsh Cancer Research Laboratory, Kolling Institute of Medical Research, Sydney, New South Wales, Australia
  14. 14 Mid North Coast Cancer Institute, Coffs Harbour Hospital, Coffs Harbour, New South Wales, Australia
  15. 15 Illawarra Shoalhaven Cancer and Haematology Network, Wollongong Hospital, Wollongong, New South Wales, Australia
  1. Correspondence to Dr Antony J Mersiades; antony.mersiades{at}gmail.com

Abstract

Introduction Chemotherapy-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.

  • cannabis
  • cannabidiol
  • chemotherapy-induced nausea and vomiting
  • randomized trial
  • antiemetic

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2017-020745

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    Footnotes

    • Contributors PG, PSH, MS, NL, JS, IM, IO, DJA, CG and ACK were responsible for study concept (grant authors). PG, PSH, MS, NL, JS, IM, IO, DJA, CG, ACK, RLM and NW were responsible for protocol development. PG, AT, AJM, NW, AW, CH, ACK, MS, CG, PF, SC, KB and MA were responsible for study conduct.

    • Funding NSW Department of Health, drug supply by Tilray.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval This protocol was approved at the Sydney Local Health District ethics review committee (Royal Prince Alfred Hospital zone) and ethics review committees for all participating sites.

    • Provenance and peer review Not commissioned; externally peer reviewed.