CancerCAN-RWENCT05863910
Real World Evidence on the Use of Medical Cannabis in Pediatrics
An observational study of Cancer and Epilepsy, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Cancer, Epilepsy, Neurodevelopmental Disorders
- What is being tested?
- Medical Cannabis
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Population includes children (3 to 17 years) who are cannabis-naïve or experienced with a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use o medical cannabis primarily for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management.
Who may be able to join
- 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
Who cannot join
- individuals using cannabis for medical purposes without a medical cannabis authorization from a health care provider
- those only using cannabis recreationally
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
U Manitoba
Winnipeg, Manitoba, R3E0T6
Lauren Kelly, PhD, 2042723149, lauren.kelly@umanitoba.ca
About this study
Official title: Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study
CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.
Read the 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.
- Conditions
- Cancer, Epilepsy, Neurodevelopmental Disorders
- Being tested
- Medical Cannabis
- Keywords
- cannabinoids, cannabis, pediatrics
- Medical subject headings
- Neoplasms, Epilepsy, Neurodevelopmental Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisDrug
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Medical Cannabis | |
| 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] Receives: Drug: Medical Cannabis | |
| General Pediatrics Cohort | There are no specific outcome scales added for this cohort. Receives: Drug: Medical Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 24-months
Secondary outcomes (12)
Effectiveness in seizure cohort - seizure frequency
Longitudinal assessment for benefit signals in epilepsy seizure frequency/severity measure by a seizure diary
Measured: baseline to 24-months
Effectiveness in seizure cohort - QOLCE
Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE
Measured: baseline to 24-months
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
Measured: baseline to 24-months
Effectiveness in oncology cohort - cachexia
Longitudinal assessment of cachexia using Peds-FAACT
Measured: baseline to 24-months
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
Measured: baseline to 24-months
Family related quality of life
Longitudinal assessment of cachexia using PedsQL
Measured: baseline to 24-months
Changes in mood - anxiety
PROMIS short form scales for pediatric anxiety symptoms 8a v2.0
Measured: baseline to 24-months
Changes in mood - depression
PROMIS short form scales for pediatric depression symptoms 8a v2.0
Measured: baseline to 24-months
Changes in mood - positive affect
PROMIS short form pediatric positive affect scale 8a v2.0
Measured: baseline to 24-months
Changes in sleep related impairment
PROMIS short form pediatric sleep related impairment scale 8a v2.0
Measured: baseline to 24-months
Changes in pain interference
PROMIS short form pediatric pain interference scale 8a v2.0
Measured: baseline to 24-months
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.
Measured: baseline-24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start20 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- The Canadian Collaborative for Childhood Cannabinoid Therapeutics, Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Sapna Oberoi, MD, Principal investigator, University of ManitobaTaylor Lougheed, MD, Principal investigator, Northern Ontario School of MedicineEvan Lewis, MD, Principal investigator, Neurology Centre of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863910
- Sponsor's protocol ID
- CAN-RWE
- Acronym
- CAN-RWE
- Status last verified
- Nov 2023
- First submitted
- 13 Feb 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: summary level data will be available upon reasonable request with appropriate approval and oversight of a research ethics board.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05863910
- Acronym / sponsor ID
- CAN-RWE / CAN-RWE
- Conditions
- Cancer, Epilepsy, Neurodevelopmental Disorders
- Keywords
- cannabinoids, cannabis, pediatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- The Canadian Collaborative for Childhood Cannabinoid Therapeutics, Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epilepsy Cohort | – | Drug: Medical CannabisFor 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 |
| Cancer Cohort | – | Drug: Medical CannabisFor 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] |
| General Pediatrics Cohort | – | Drug: Medical CannabisThere are no specific outcome scales added for this cohort. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Population includes children (3 to 17 years) who are cannabis-naïve or experienced with a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use o medical cannabis primarily for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- individuals using cannabis for medical purposes without a medical cannabis authorization from a health care provider
- those only using cannabis recreationally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisAny cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study. | Drug | Cancer Cohort, Epilepsy Cohort, General Pediatrics Cohort |
Primary outcome
Patterns of cannabis use (caregiver-reported)
Time frame: 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
12 secondary outcomes
Effectiveness in seizure cohort - seizure frequency
Time frame: baseline to 24-months
Effectiveness in seizure cohort - QOLCE
Time frame: baseline to 24-months
Effectiveness in oncology cohort - symptom burden
Time frame: baseline to 24-months
Effectiveness in oncology cohort - cachexia
Time frame: baseline to 24-months
Adverse events
Time frame: baseline to 24-months
Family related quality of life
Time frame: baseline to 24-months
Changes in mood - anxiety
Time frame: baseline to 24-months
Changes in mood - depression
Time frame: baseline to 24-months
Changes in mood - positive affect
Time frame: baseline to 24-months
Changes in sleep related impairment
Time frame: baseline to 24-months
Changes in pain interference
Time frame: baseline to 24-months
Parental overall impression of behaviour
Time frame: baseline-24months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- For more information on our research team visit our website.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. summary level data will be available upon reasonable request with appropriate approval and oversight of a research ethics board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sapna Oberoi, MD principal investigator
University of Manitoba
Taylor Lougheed, MD principal investigator
Northern Ontario School of Medicine
Evan Lewis, MD principal investigator
Neurology Centre of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Epilepsy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren E Kelly, PhD (2042723149, lauren.kelly@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of cannabis use (caregiver-reported) (time frame: baseline to 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.