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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
60
High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. The MPL-001 oil is produced by MediPharm Labs, each ml contains 50mg CBD and 2mg THC.
Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. The MPL-005 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 5mg THC.
Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. The MPL-009 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 25mg THC.
Incidence of adverse events (Tolerability)
Reported through study completion
Time frame: 14 weeks
Pain intensity
Pain will be measured using Faces Pain Scale-Revised reported by the participants daily throughout the study. Pain will be reported for each study visit as a percentage change from the weekly average documented at baseline.
Time frame: daily for 14 weeks
Symptom burden
Symptom burden is measured using the score of Symptom Screening in Pediatrics Tool (SSPedi) assessed three times a week throughout the study and will be reported as a weekly average and percentage change from baseline.
Time frame: 3 times per week for 14 weeks
Quality of life (child)
Pediatric quality of life inventory (PedsQLTM) will be assessed weekly throughout the study
Time frame: once per week for 14 weeks
Sleep (hours per night)
Sleep, will be reported as the number of hours per night, measured using Actigraphy and/or parent report, will be reported as an average over a one-week time period.
Time frame: daily for 14 weeks
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