Medicinal cannabis for children with cancer: the mini trial

Abstract

Introduction 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. Methods The primary aim of this prospective, multicentre, randomised, blinded, two-arm parallel trial, is to establish the tolerable and potentially effective dose of two medicinal cannabis oil investigational products (Little Green Pharma, Australia), for children and young people with advanced cancer. The secondary outcomes are the symptom control of each individual symptom per investigational product, and each child's total symptom control per investigational product. Participants aged 6 months to 21 years will be randomised to receive a CBD:THC equivalent product (10 mg:10 mg), or a CBD dominant product (100 mg CBD:1 mg THC). Following a 2-week Baseline Phase, participants will slowly titrate the investigational product up over a 2-week period (Titration Phase). The maximum dose achieved during the 2-week Titration Phase will be continued for 4 weeks (Maintenance Phase). Participants will be assessed weekly for symptom control and adverse events. Results As this is an ongoing clinical trial, we will present the study protocol and study progress to date. Conclusions This research may benefit children and young people in future as information collected will help us to better understand how medicinal cannabis works, which can help inform prescribing practice.L6384740442022-07-20 <br />