Oral Presentation Palliative Care Nurses Australia Conference 2022

Medicinal Cannabis for Children with Advanced Cancer: The MINI Trial (#28)

Alison Bowers 1 , Helen Heussler 2 , Helen Irving 3 , Murray Mitchell 4 , Iain McGregor 5 , Geoff Wallace 2 , Natalie Bradford 1 , Michael Duhig 2 , Janet Hardy 6 , Phillip Good 6 , Ross Drake 7 , Bronwyn Sacks 8 , Molly Williams 8 , Jenny Hynson 8 , Frank Alvero 9 , Sharon Ryan 9 , Paul Lee-Archer 10 , Christine Mott 11 , Anthony Herbert 1 11
  1. Cancer and Palliative Care Outcomes Centre, Centre for Healthcare Transformation, School of Nursing, Queensland University of Technology, Brisbane, Queensland, Australia
  2. Centre for Clinical Trials in Rare Neurodevelopmental Disorders, Children's Health Queensland, Brisbane, Queensland, Australia
  3. Oncology Services, Children's Health Queensland, Brisbane, Queensland, Australia
  4. School of Biomedical Sciences, Queensland University of Technology, Brisbane, Queensland, Australia
  5. The Lambert Initiative, University of Sydney, Sydney, New South Wales, Australia
  6. Palliative and Supportive Care, Mater Research - University of Queensland, Brisbane, Queensland, Australia
  7. Starship Children’s Hospital, Auckland, New Zealand
  8. Victorian Paediatric Palliative Care , Royal Children’s Hospital, Melbourne, Victoria, Australia
  9. John Hunter Children’s Hospital, Newcastle, New South Wales, Australia
  10. Children's Health Queensland, Brisbane, Queensland, Australia
  11. Paediatric Palliative Care, Children's Health Queensland, South Brisbane, Queensland, Australia

Introduction: The use of medicinal cannabis for managing cancer related symptoms is increasing, yet there remains little evidence to inform prescribing, especially in the paediatric population.

Aims: The aims of this prospective multi-site, double-blinded, randomised clinical trial, is to determine tolerability and potentially effective dose of two medicinal cannabis products, for treating symptoms in children receiving palliative care for advanced cancer.

Methods: Children and young people aged 6 months to 21 years will be randomised to received a CBD:THC equivalent product (10mg:10mg) or a CBD dominant product (100mg:1mg). After a two-week baseline assessment phase, participants will commence titrating up the investigational product for a two-week period (titration phase). They will then continue on the maximum dose achieved during the titration phase for four weeks (maintenance phase). Participant's symptoms and adverse effects will be monitored weekly throughout the trial. Surveys, actigraphy, blood tests and clinical assessments will be used to monitor outcomes of interest and ongoing safety. At the end of the maintenance phase participants will titrate off the investigational product, or continue to receive medicinal cannabis under the Special Access Scheme. 

Results: This research is ongoing. Australian and New Zealand Clinical Trials Registry ACTRN12622000037707.

Conflict of interest: Dr Bowers is a member of the 2022 PCNA Conference Organising Committee.

Funding: This study is funded by a Medical Research Future Fund (MRFF) grant.

Both investigational products are being supplied by Little Green Pharma free of charge.