e-Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2021

Definitive randomised double-blind placebo-controlled trial evaluating an oral cannabinoid-rich THC/CBD cannabis extract for chemotherapy-induced nausea and vomiting (CINV) – Trial in progress (#401)

Antony Mersiades 1 2 , Annette Tognela 3 , Adrienne Kirby 1 , Martin Stockler 1 4 5 6 , Nicholas Lintzeris 4 7 , John Simes 1 5 , Paul Haber 4 , Ian Olver 8 , Ehtesham Abdi 9 10 , Stephen Della-Fiorentina 11 , Peter Fox 12 , Morteza Aghmesheh 13 , Matthew Chan 14 , Ganessan Kichendadasse 15 , Karen Briscoe 16 , Helen Wheeler 17 , Jasotha Sanmugarajah 18 , Rachael L Morton 1 , Mbathio Dieng 1 , Anna Walsh 1 , Yvonne Lee 1 , Peter Grimison 1 5
  1. NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia
  2. Northern Beaches Hospital, Frenchs Forest, NSW, Australia
  3. Medical Oncology, Macarthur Cancer Therapy Centre, South Western Sydney Local Health District, Campbelltown, NSW, AUSTRALIA
  4. Sydney Medical School, University of Sydney, Camperdown, NSW, AUSTRALIA
  5. Chris O'Brien Lifehouse, Camperdown, NSW, AUSTRALIA
  6. Concord Cancer Centre, Concord, NSW, AUSTRALIA
  7. Drug and Alcohol Services, South East Sydney Local Health District, Concord, NSW, AUSTRALIA
  8. School of Psychology, Faculty of Health and Medical Services, University of Adelaide, Adelaide, SA, Australia
  9. Faculty of Health Services, Southern Cross University, Gold Coast, QLD, Australia
  10. The Tweed Hospital, Tweed Heads, NSW, Australia
  11. Southern Highlands Cancer Centre, Bowral, NSW, Australia
  12. Central West Cancer Care Centre, Orange Health Service, Orange, NSW, AUSTRALIA
  13. Illawarra Cancer Care Centre, Illawarra Shoalhaven Local Health District, Wollongong, NSW, AUSTRALIA
  14. Central Coast Cancer Centre, Gosford Hospital, Gosford, NSW, Australia
  15. Flinders Medical Centre, Bedford Park, SA, Australia
  16. Mid-North Coast Cancer Institute, Coffs Harbour Hospital, Coffs Harbour, NSW, AUSTRALIA
  17. Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA
  18. Gold Coast University Hospital, Southport, QLD, Australia

Background: Chemotherapy-induced nausea and vomiting (CINV) is experienced by up to half of patients receiving chemotherapy of moderate or high emetic risk, despite optimal anti-emetic prophylaxis (Gilmore, JOP, 2014). The initial, phase 2, double-blind, crossover component of this trial randomised 81 patients with refractory CINV to receive THC/CBD or placebo for Cycle A, and the alternate agent for Cycle B.   THC/CBD increased the frequency of ‘complete response’ (no vomiting and no use of rescue medications, 0-120 hours) from 14% to 25% compared with placebo (p=0.04).   Treatment was well tolerated, with no serious adverse events attributed to THC/CBD.  The frequencies of the commonest cannabis-associated side effects rated moderate or severe were sedation, 19%. and dizziness, 10%, (Grimison, Annals of Onc, 2020). The overall aim of this multi-centre, randomised, placebo-controlled, seamless, phase 2/3 trial is to determine efficacy of addition of an oral cannabinoid-rich THC/CBD cannabis extract for control of CINV.

Methods: The target population is adults experiencing CINV during moderate and highly emetogenic chemotherapy regimens despite appropriate anti-emetic prophylaxis, scheduled to receive at least 2 more consecutive cycles of chemotherapy. Participants are randomised 1:1 to receive oral THC 2.5mg/CBD 2.5mg (Tilray TN-TC11M) capsules or placebo, administered 3 times a day on days -1 to 5, in addition to guideline-consistent anti-emetics, including rescue medications.  The primary endpoint is the proportion of patients gaining a complete response in Cycle A; secondary outcomes include: (i) no emesis, (ii) no significant nausea, (iii) no use of rescue medication, (iv) complete response and no significant nausea, (v) adverse events, (vi) quality of life, and (vii) health economics. 

Results: Trial in progress.  ACTRN12616001036404.  As of 31st July 2021, 127/250 patients recruited.

Funding: NSW Department of Health.

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