- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05754840
CANnabinoids in Pediatric ONCology (CAN-PONC)
A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Lauren Kelly, PhD
- Phone Number: 204-242-3179
- Email: lauren.kelly@umanitoba.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 4-18 years old at the time of enrollment
- Diagnosed with relapsed or refractory solid or hematologic malignancy
- Currently receiving active cancer treatment or palliative care
- Estimated survival of at least 4 months at the time of enrollment
Exclusion Criteria:
- 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
- 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
- Children with a personal or family history of schizophrenia or psychotic disorders, substance use disorder or allergy to cannabinoids or cannabis
- Unwilling or unable to use effective form of contraception and refrain from driving throughout the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1. High-CBD arm (MPL-001)
High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD.
|
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.
|
Experimental: Arm 2. Medium-CBD arm (MPL-005)
Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD.
|
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.
|
Experimental: Arm 3. Balanced arm (MPL-009)
Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (Tolerability)
Time Frame: 14 weeks
|
Reported through study completion
|
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: daily for 14 weeks
|
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.
|
daily for 14 weeks
|
Symptom burden
Time Frame: 3 times per week for 14 weeks
|
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.
|
3 times per week for 14 weeks
|
Quality of life (child)
Time Frame: once per week for 14 weeks
|
Pediatric quality of life inventory (PedsQLTM) will be assessed weekly throughout the study
|
once per week for 14 weeks
|
Sleep (hours per night)
Time Frame: daily for 14 weeks
|
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.
|
daily for 14 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rod Rassekh, MD, University of British Columbia
- Principal Investigator: Bruce Crooks, MD, Dalhousie University
- Principal Investigator: Adam Rappoport, MD, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CAN-PONC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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