Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754840
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-02-13
Brief Title:
CANnabinoids in Pediatric ONCology
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
A Randomized Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer the CAN-PONC Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAN-PONC
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 childrens hospitals
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 THCCBD 125 arm 1 15 arm 2 and 11 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 11 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 112 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
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 11 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 112 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None