Overview

CANnabinoids in Pediatric ONCology

Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Manitoba
Collaborators:
Canadian Cancer Society (CCS)
Canadian Institutes of Health Research (CIHR)
The Canadian Collaborative for Childhood Cannabinoid Therapeutics
Criteria
Inclusion Criteria:

1. Ages 4-18 years old at the time of enrollment

2. Diagnosed with relapsed or refractory solid or hematologic malignancy

3. Currently receiving active cancer treatment or palliative care

4. Estimated survival of at least 4 months at the time of enrollment

Exclusion Criteria:

1. History of cardiovascular disease, severe hepatic or renal impairment defined by
ALT/AST more than 5x ULN, creatinine more than 5x ULN or GFR >60, unstable/unmanaged
arrhythmias, uncontrolled hypertension with blood pressure above 99%ile for age or
history of myocardial infarction

2. 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

3. 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

4. Participation in other clinical trials that prohibit the concurrent use of cannabis

5. Children with a personal or family history of schizophrenia or psychotic disorders,
substance use disorder or allergy to cannabinoids or cannabis

6. Unwilling or unable to use effective form of contraception and refrain from driving
throughout the study period