CANnabinoids in Pediatric ONCology
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4-18
SponsorUniversity of Manitoba
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 4-17 years old at the time of enrollment
Diagnosed with relapsed or refractory solid or hematologic malignancy including brain tumours
Currently receiving active cancer treatment or supportive and palliative care
Estimated survival of at least 4 months at the time of enrollment
Disqualifiers
History of cardiovascular disease, severe hepatic or renal impairment defined by alanine transaminase (ALT)/ aspartate aminotransferase (AST) more than 5x upper limit of normal (ULN), creatinine more than 5x ULN or glomerular filtration rate (GFR less than) <60 mL/min/1.73 m273m2, unstable/unmanaged arrhythmias, uncontrolled hypertension with blood pressure above 99th centile for age or history of myocardial infarction
Nabilone or other cannabis-based products use (including for recreational purposes) within the past 2 weeks or planned nabilone use for the duration of their enrollment in the trial. Current use/continued use of recreational cannabis, or not willing to abstain from recreational cannabis use during the trial
Anyone who is pregnant or breast/chest-feeding throughout the duration of the study or has the intention to become pregnant within 3 months of study completion
Participation in other clinical trials that prohibit the concurrent use of cannabis
Trial design
Design model
Parallel
Treatments tested in this trial
MPL-001
DrugHigh-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.
MPL-005
DrugMedium-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.
MPL-009
DrugBalanced 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Arm 1. High-CBD arm (MPL-001)Experimental treatment 1 intervention
Group B: Arm 2. Medium-CBD arm (MPL-005)Experimental treatment 1 intervention
Group C: Arm 3. Balanced arm (MPL-009)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events (Tolerability)
Reported through study completion
Time frame
14 weeksSecondary outcomes
1
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 weeks2
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 weeks3
Quality of life (child)
Pediatric quality of life inventory (PedsQLTM) will be assessed weekly throughout the study
Time frame
once per week for 14 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manitoba
Lead sponsor
Canadian Cancer Society (CCS)
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov