Exploring medicinal cannabis for children in palliative care
A Pilot Study of Medicinal Cannabis in Paediatric Patients Undergoing Palliative Care for Non-oncological Conditions
This study is testing whether medicinal cannabis can help relieve symptoms in children aged 6 months to 21 years who are in palliative care for non-cancer conditions.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 6 Months to 21 Years |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 1 site (Parkville, Victoria) |
| Trial ID | NCT05615389 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility and acceptability of using medicinal cannabis to alleviate symptoms in children aged 6 months to 21 years who are receiving palliative care for non-oncological conditions. Participants will be randomly assigned to receive one of two medicinal cannabis products, with the study being double-blind to ensure unbiased results. The primary focus is to evaluate the study design, including recruitment strategies and medication tolerability, to inform a larger multi-centre trial in the future. Additionally, preliminary safety data will be collected on the two cannabis formulations used in the trial.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 21 years receiving palliative care for non-oncological conditions with significant symptom burden.
Not a fit: Patients with a history of psychosis or major depressive disorders, or those whose parents do not speak English, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for managing symptoms in pediatric patients undergoing palliative care.
How similar studies have performed: While the use of medicinal cannabis in palliative care is gaining interest, this specific approach in pediatric populations is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females aged 6 months to 21 years of age; 2. Receiving care in the Victorian Paediatric Palliative Care Program for a non-oncological condition; 3. Pain, dystonia and/or gut dysfunction parent-rated symptom score above threshold, defined by rating on the relevant revised Memorial Symptom Assessment Scale (MSAS) question(s) of: 1. Frequency: "Frequently" or "Almost Constantly", AND 2. Severity: "Moderate", "Severe", or "Very Severe", AND 3. Distress: "Quite a bit", or "Very much"; 4. No changes in medication or other interventions in the two weeks prior to randomization; 5. Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator; 6. Agrees not to drive for the duration of the study. Exclusion Criteria: 1. Non-English speaking parents. 2. Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a first degree family history of psychosis. 3. Taking medications which are known to interact with medicinal cannabis: warfarin, mTOR inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day. 4. Abnormal liver function tests defined as ALT \> 3 x ULN 5. Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening 6. Pregnant or intending to become pregnant during the study, or breastfeeding. 7. History of clinically significant suicidal thoughts in the prior 12 months. 8. Life expectancy less than 3 months in the opinion of the investigators 9. Allergy to any of the components in the investigatory products (eg sunflower oil) 10. Diagnosis of a malignant condition
Where this trial is running
Parkville, Victoria
- Royal Children's Hospital / Murdoch Children's Research Institute — Parkville, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: A/Prof Daryl Efron — Murdoch Childrens Research Institute
- Study coordinator: A/Prof Daryl Efron
- Email: mctrials@mcri.edu.au
- Phone: +61 (3) 8341 6200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.