Cancer Clinical Trial
Official title:
A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial
CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals.
This is a multi-centered, pragmatic, double-blind, adaptive, dose-escalation study to establish the tolerability of Cannabis Herbal Extracts (CHE) containing different ratios of delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Study arms will contain the following ratios THC:CBD 1:25 (arm 1), 1:5 (arm 2) and 1:1 (arm 3). CAN-PONC will enroll 20 participants recruited into each arm, for a total of 60 study participants. To inform the dose for the arm containing the most THC, this study will take place in two stages. In Stage One: The first 20 participants will be randomized 1:1 into arm 1 and arm 2. Once 20 participants have been recruited, trial recruitment will halt until the last participant reaches the maintenance phase, the maximum THC dose at which less than 30% of participants reported dose limiting toxicities (Max-D30) has been established, the remaining 40 recruited participants will be randomized 1:1:2 into arm 1, arm 2 and arm 3 in Stage Two of this study. All arms consist of three phases: baseline phase (no interventional product for two weeks), treatment phase (dose escalations for eight weeks), and a maintenance phase (maximum tolerated dose for four weeks). ;
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