CAN-RWE: Real World Evidence on the Use of Medical Cannabis in Pediatrics

• Sponsor: University of Manitoba (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05863910
• Collaborator: The Canadian Collaborative for Childhood Cannabinoid Therapeutics (Other), Canadian Cancer Society (CCS) (Other), Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 500
• Anticipated Duration (Months): 54.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer; Epilepsy; Neurodevelopmental Disorders	Drug: Medical Cannabis

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study
• Anticipated Study Start Date: Jun 6, 2023
• Anticipated Primary Completion Date: Dec 31, 2027
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Epilepsy Cohort For children with epilepsy, the following tools will be added for data collection at each time point: Side effects: Pediatric Epilepsy Side Effects Questionnaire [PESQ] Seizure frequency/severity: Seizure Diary Data Questionnaire	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.
Cancer Cohort For children with cancer, the following tools will be added for data collection at each time point: Cancer symptom burden: Symptom Screening in Pediatrics Tool [SSPedi] Cachexia: Pediatric Functional Assessment of Anorexia/ Cachexia Treatment [peds-FAACT]	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.
General Pediatrics Cohort There are no specific outcome scales added for this cohort.	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.

Outcome Measures

Primary Outcome Measures

1. Patterns of cannabis use (caregiver-reported) [baseline to 24-months]

   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

Secondary Outcome Measures

1. Effectiveness in seizure cohort - seizure frequency [baseline to 24-months]

   Longitudinal assessment for benefit signals in epilepsy seizure frequency/severity measure by a seizure diary

2. Effectiveness in seizure cohort - QOLCE [baseline to 24-months]

   Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE

3. Effectiveness in oncology cohort - symptom burden [baseline to 24-months]

   Longitudinal assessment for benefit signals in caregiver reported changes in symptom burden assessed using mini-SSPEDI (under 8 yr) and SSPEDI scales

4. Effectiveness in oncology cohort - cachexia [baseline to 24-months]

   Longitudinal assessment of cachexia using Peds-FAACT

5. Adverse events [baseline to 24-months]

   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

6. Family related quality of life [baseline to 24-months]

   Longitudinal assessment of cachexia using PedsQL

7. Changes in mood - anxiety [baseline to 24-months]

   PROMIS short form scales for pediatric anxiety symptoms 8a v2.0

8. Changes in mood - depression [baseline to 24-months]

   PROMIS short form scales for pediatric depression symptoms 8a v2.0

9. Changes in mood - positive affect [baseline to 24-months]

   PROMIS short form pediatric positive affect scale 8a v2.0

10. Changes in sleep related impairment [baseline to 24-months]

    PROMIS short form pediatric sleep related impairment scale 8a v2.0

11. Changes in pain interference [baseline to 24-months]

    PROMIS short form pediatric pain interference scale 8a v2.0

12. Parental overall impression of behaviour [baseline-24months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Manitoba
• The Canadian Collaborative for Childhood Cannabinoid Therapeutics
• Canadian Cancer Society (CCS)
• Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Sapna Oberoi, MD, University of Manitoba
• Principal Investigator: Taylor Lougheed, MD, Northern Ontario School of Medicine
• Principal Investigator: Evan Lewis, MD, Neurology Centre of Toronto

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: University of Manitoba
• ClinicalTrials.gov Identifier: NCT05863910
• Other Study ID Numbers: CAN-RWE
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Manitoba: cannabinoids; cannabis; pediatrics
• Additional relevant MeSH terms: Marijuana Abuse; Neurodevelopmental Disorders

Study Results

No Results Posted as of May 18, 2023