Pilot Study of MC in Paediatric Palliative Care

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Nov 7, 2022

Keywords

ClinConnect Summary

This pilot study is investigating the use of medicinal cannabis to help relieve symptoms in children receiving palliative care for non-cancer-related conditions. The main goal is to see how practical and acceptable it is for families to participate in a larger clinical trial. Researchers will look at how well the study is set up, how well children tolerate the medication, and the overall outcomes to ensure that it’s a good fit for families involved in palliative care.

To be eligible for this study, children aged between 6 months and 21 years must be receiving care in the Victorian Paediatric Palliative Care Program and have significant symptoms like pain or gut issues. Participants will be randomly assigned to receive one of two different medicinal cannabis products, and neither the families nor the researchers will know which product is given until the end of the trial. Families can expect to follow specific guidelines throughout the study and will help provide valuable information that could lead to a larger trial in the future.

Gender

ALL

Eligibility 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