Real World Evidence on the Use of Medical Cannabis in Pediatrics

Cancer Clinical Trial

— CAN-RWE  

Official title:

Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863910
• Other study ID #: CAN-RWE
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: Lauren E Kelly, PhD
• Phone: 2042723149
• Email: lauren.kelly[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.

Description:

Pediatric patients (3 to 17 years) using medical cannabis (MC) for pain, sleep, mood, behaviour, seizures, treatment of cancer, or to manage symptoms related to cancer or cancer-treatment are eligible to join this 24-month study if they have a valid MC authorization.

Following screening, eligible participants will be contacted by the study coordinator. Following informed consent, study participants will record complete outcome measures on pain, sleep, mood (anxiety, depression and positive affect), behaviour, as well as report their cannabis use and indication-specific outcomes as applicable at 3, 6, 12, and 18 weeks, as well as 6, 12, 18 and 24-months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• 3 to 17 years

• have a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use of medical cannabis

• medical cannabis is authorized for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management

• ability to respond to electronic questionnaires in English

Exclusion Criteria:

• individuals using cannabis for medical purposes without a medical cannabis authorization from a health care provider

• those only using cannabis recreationally

Related Conditions & MeSH terms

• Cancer
• Epilepsy
• Neurodevelopmental Disorders

Intervention

Drug:
• Medical Cannabis
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.

Locations

Country	Name	City	State
Canada	U Manitoba	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), The Canadian Collaborative for Childhood Cannabinoid Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns of cannabis use (caregiver-reported)	Describe patterns of cannabis use are described using a standard data collection form including dose and product type completed by caregivers at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months	baseline to 24-months
Secondary	Effectiveness in seizure cohort - seizure frequency	Longitudinal assessment for benefit signals in epilepsy seizure frequency/severity measure by a seizure diary	baseline to 24-months
Secondary	Effectiveness in seizure cohort - QOLCE	Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE	baseline to 24-months
Secondary	Effectiveness in oncology cohort - symptom burden	Longitudinal assessment for benefit signals in caregiver reported changes in symptom burden assessed using mini-SSPEDI (under 8 yr) and SSPEDI scales	baseline to 24-months
Secondary	Effectiveness in oncology cohort - cachexia	Longitudinal assessment of cachexia using Peds-FAACT	baseline to 24-months
Secondary	Adverse events	Cannabis-related adverse events and serious adverse events reported by caregivers using a standard AE data collection tool and categorized according to CTCAE v5.0 at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months	baseline to 24-months
Secondary	Family related quality of life	Longitudinal assessment of cachexia using PedsQL	baseline to 24-months
Secondary	Changes in mood - anxiety	PROMIS short form scales for pediatric anxiety symptoms 8a v2.0	baseline to 24-months
Secondary	Changes in mood - depression	PROMIS short form scales for pediatric depression symptoms 8a v2.0	baseline to 24-months
Secondary	Changes in mood - positive affect	PROMIS short form pediatric positive affect scale 8a v2.0	baseline to 24-months
Secondary	Changes in sleep related impairment	PROMIS short form pediatric sleep related impairment scale 8a v2.0	baseline to 24-months
Secondary	Changes in pain interference	PROMIS short form pediatric pain interference scale 8a v2.0	baseline to 24-months
Secondary	Parental overall impression of behaviour	Parents/Caregivers will be asked to report on if their childs behaviour has improved or worsened and will have an open-ended text box to describe anything they want to tell us about changes in their child's behaviour.	baseline-24months

External Links

•   For more information on our research team visit our website.