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Medicinal cannabis for treating symptoms in children with cancer receiving palliative care

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Abstract Description

Institution: Queensland University of Technology - Queensland, Australia

Background: The prescribing of medicinal cannabis is becoming more frequent, yet there remains little evidence for the efficacy and safety of these products in patients with advanced cancer, especially the paediatric population. To help address the gaps in evidence, a collaborative team of clinicians and researchers, were awarded a competitive grant under the MRFF Emerging Priorities and Consumer Driven Research initiative, to conduct a clinical trial using medicinal cannabis. 

Aims: The primary aim of this clinical trial is to establish the tolerable and potentially effective dose, that is the dose that achieves symptom relief with acceptable side effects, of the two medicinal cannabis products. The secondary aim is to explore symptom control of each child’s individual symptom and total symptom burden for each Investigational Product. 

Methods: This is a prospective multi-site, double-blinded, randomised clinical trial will recruit children and young people aged 6 months to 21 years. Participants will be randomised to received one of two medicinal cannabis oil products.

Each participant will be in the trial for up to 8 consecutive weeks. In weeks 1 and 2, participant baseline assessments will be conducted (Baseline Phase). In weeks 3 and 4, participants will receive either a CBD:THC equivalent product (10mg:10mg) or a CBD dominant product (100mg:1mg), in accordance with their randomisation allocation, with the Investigational product being slowly titrated up until an effective dose is reached (Titration Phase). Participants will continue on the effective does for a further 4 weeks (Maintenance Phase). Assessments and monitoring will be conducted for the duration of the trial and once after participation ends. At the end of the trial, participants will titrate off the Investigational Product, or continue to receive medicinal cannabis under the Special Access Scheme.

Results: This is an ongoing clinical trial. We will present progress to date.

Presenters

Dr Alison Bowers

Research Fellow
Centre for Healthcare Transformation, Cancer and Palliative Care Outcomes Centre, Queensland University of Technology - Brisbane, Australia

Associate Professor Anthony Herbert

Director of the Paediatric Palliative Care Service
Children's Health Queensland Hospital and Health service

Authors

Authors

A/Prof Anthony Herbert - Queensland University of Technology and Children's Health Queensland Hospital and Health Service , A/Prof Helen Heussler - Children's Health Queensland Hospital and Health Service, Centre for Clinical Trials in Rare Neurodevelopmental Disorders , Prof Iain McGregor - The University of Sydney, Lambert Initiative , A/Prof Natalie Bradford - Centre for Healthcare Transformation, Cancer and Palliative Care Outcomes Centre, Queensland University of Technology , Prof Janet Hardy - Mater Research - The University of Queensland , Dr Bronwyn Sacks - Royal Children's Hospital, Melbourne , Dr Geoff Wallace - Children's Health Queensland Hospital and Health Service, Centre for Clinical Trials in Rare Neurodevelopmental Disorders , A/Prof Phillip Good - Mater Research - The University of Queensland , Dr Ross Drake - Starship Children's Health, New Zealand , Dr Molly Williams - Royal Children's Hospital, Melbourne , A/Prof Jenny Hynson - Royal Children's Hospital, Melbourne , Dr Frank Alvaro - John Hunter Children's Hospital, Newcastle , Dr Sharon Ryan - John Hunter Children's Hospital, Newcastle , Dr Paul Lee-Archer - Children's Health Queensland Hospital and Health Service , Dr Christine Mott - Children's Health Queensland Hospital and Health Service , Dr Alison Bowers - Centre for Healthcare Transformation, Cancer and Palliative Care Outcomes Centre, Queensland University of Technology , Mr Michael Duhig - Children's Health Queensland Hospital and Health Service, Centre for Clinical Trials in Rare Neurodevelopmental Disorders , Helen Irving - , Prof Murray Mitchell - Queensland University of Technology

Palliative Care Australia Limited