NCT05754840 CANnabinoids in Pediatric ONCology
| NCT ID | NCT05754840 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Manitoba |
| Condition | Childhood Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-07-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Ages 4-17 years old at the time of enrollment 2. Diagnosed with relapsed or refractory solid or hematologic malignancy including brain tumours 3. Currently receiving active cancer treatment or supportive and 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 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 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 motorized vehicles (cars, motorcycles, boats, etc.) throughout the study period 7. Anyone who is currently receiving cell therapies or immune checkpoint inhibitors
Contact & Investigator
Rod Rassekh, MD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05754840 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Childhood Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05754840 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05754840 currently recruiting?
Yes, NCT05754840 is actively recruiting participants. Contact the research team at lauren.kelly@umanitoba.ca for enrollment information.
Where is the NCT05754840 trial being conducted?
This trial is being conducted at Vancouver, Canada, Halifax, Canada, Toronto, Canada.
Who is sponsoring the NCT05754840 clinical trial?
NCT05754840 is sponsored by University of Manitoba. The principal investigator is Rod Rassekh, MD at University of British Columbia. The trial plans to enroll 60 participants.
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