Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

Pilot and definitive randomised double-blind placebo-controlled trials evaluating an oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting (CINV) (#265)

Antony Mersiades 1 , Annette Tognela 2 , Paul Haber 3 , Martin Stockler 1 4 5 , Nicholas Lintzeris 3 6 , John Simes 1 4 , Iain McGregor 7 , Ian Olver 8 , David J Allsop 3 , Craig Gedye 9 , Adrienne Kirby 1 , Stephen Clarke 10 11 , Peter Fox 12 , Karen Briscoe 13 , Morteza Aghmesheh 14 , Nicole Wong 1 , Anna Walsh 1 , Carmel Hahn 4 , Peter Grimison 1 4
  1. NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, AUSTRALIA
  2. Macarthur Cancer Therapy Centre, South Western Sydney Local Health District, Campbelltown, NSW, AUSTRALIA
  3. Sydney Medical School, University of Sydney, Camperdown, NSW, AUSTRALIA
  4. Chris O'Brien Lifehouse, Camperdown, NSW, AUSTRALIA
  5. Concord Cancer Centre, Concord, NSW, AUSTRALIA
  6. Drug and Alcohol Services, South East Sydney Local Health District, Concord, NSW, AUSTRALIA
  7. Lambert Initiative for Cannabinoid Therapeutics, University of Sydney, Camperdown, NSW, AUSTRALIA
  8. Sansom Institute for Health Research, University of South Australia, Adelaide, SA, AUSTRALIA
  9. Department of Medical Oncology, Calvary Mater Newcastle, Newcastle, NSW, AUSTRALIA
  10. Northern Cancer Institute, St Leonards, NSW, AUSTRALIA
  11. Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA
  12. Central West Cancer Care Centre, Orange Health Service, Orange, NSW, AUSTRALIA
  13. Mid-North Coast Cancer Institute, Coffs Harbour Hospital, Coffs Harbour, NSW, AUSTRALIA
  14. Illawarra Cancer Care Centre, Illawarra Shoalhaven Local Health District, Wollongong, NSW, AUSTRALIA

Background:

Up to half of patients receiving chemotherapy of moderate or high emetic risk experience CINV despite optimal anti-emetic prophylaxis1.  Limited evidence suggests cannabinoid medicine in the form of tetrahydrocannabinol (THC) may reduce CINV, and addition of cannabidiol (CBD) may improve efficacy and tolerance. The aim of this multi-centre, randomised, placebo-controlled, phase II/III trial is to determine efficacy of addition of an oral cannabinoid-rich THC/CBD cannabis extract for control of CINV. 

Methods: 

Target population is adult patients experiencing CINV during moderate and highly emetogenic chemotherapy regimens despite appropriate anti-emetic therapy, who are scheduled to receive at least 2 more consecutive cycles (A, B and, where applicable, C).  Treatment consists of oral THC 2.5mg/CBD 2.5mg (Tilray TN-TC11M) capsules or placebo TDS days -1 to 5, in addition to guideline-consistent anti-emetics, including rescue medications.  In the pilot trial (N=80), subjects are randomised for cycle A, cross-over for cycle B, and nominate preferred treatment for cycle C.  In the planned definitive trial (N=250), subjects are randomised to investigational product or placebo for cycles A, B and C in a parallel design.  The primary end-point is the proportion of patients gaining a complete response (no emesis and no use of rescue medications) (0 – 120h), with additional end-points of (i) complete response, (ii) no emesis, (iii) no significant nausea and (iv) no use of rescue medication during the a) acute, b) delayed, and c) overall phases of cycle A, B and C, (iv) adverse events, (v) quality of life, and (vi) health economics. 

Results:   

Pilot trial in progress: 10 NSW sites open, 22 of 80 patients recruited.  Expected recruitment completion is April 2018. 

Funding: NSW Department of Health.

Acknowledgements: Trial participants, investigators and research staff. Drug supply by Tilray.

  1. Gilmore, J. W., Peacock, N. W., Gu, A., Szabo, S., Rammage, M., Sharpe, J., ... & Cao, X. (2013). Antiemetic guideline consistency and incidence of chemotherapy-induced nausea and vomiting in US community oncology practice: INSPIRE Study. Journal of Oncology Practice, 10(1), 68-74.