Study of Different Ratios of Cannabinoids for Symptom Management in Children Aged 4 to 17 With Cancer

What this Trial Is About

Researchers are evaluating the tolerability of different ratios of cannabinoids in children aged 4 to 17 with cancer, including those with relapsed or refractory solid or blood cancers and brain tumors. This randomized, double-blind, adaptive clinical trial is conducted across three Canadian childrens hospitals and aims to establish safe dosing for cannabis herbal extracts containing varying ratios of THC and CBD. The study involves 60 participants divided into three groups based on the cannabinoid ratio they receive. The trial has two stages initially, 20 participants are randomized between two low-THC arms THCCBD ratios of 125 and 15. After establishing the maximum tolerated THC dose with less than 30% dose-limiting toxicities, the remaining 40 participants are randomized among three arms, including a balanced 11 THCCBD ratio. Each arm involves three phases a 2-week baseline without treatment, an 8-week dose escalation treatment phase, and a 4-week maintenance phase at the maximum tolerated dose. Participants will be monitored for adverse events over 14 weeks, with daily and weekly assessments of pain intensity, symptom burden, quality of life, and sleep. The study uses quadruple blinding and randomization to ensure unbiased results. Researchers will closely track tolerability and safety while evaluating symptom management effects, with the total participation lasting approximately 14 weeks.

CANnabinoids in Pediatric ONCology