RecruitingPhase 1Phase 2NCT05615389

Pilot Study of MC in Paediatric Palliative Care

A Pilot Study of Medicinal Cannabis in Paediatric Patients Undergoing Palliative Care for Non-oncological Conditions

Sponsor

Murdoch Childrens Research Institute

Enrollment

10 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Palliative Care

Summary

The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial. Participants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial.

Eligibility

Min Age: 6 MonthsMax Age: 21 Years

Inclusion Criteria9

Males and females aged 6 months to 21 years of age;
Receiving care in the Victorian Paediatric Palliative Care Program for a non-oncological condition;
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:
Frequency: "Frequently" or "Almost Constantly", AND
Severity: "Moderate", "Severe", or "Very Severe", AND
Distress: "Quite a bit", or "Very much";
No changes in medication or other interventions in the two weeks prior to randomization;
Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;
Agrees not to drive for the duration of the study.

Exclusion Criteria10

Non-English speaking parents.
Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a first degree family history of psychosis.
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.
Abnormal liver function tests defined as ALT > 3 x ULN
Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening
Pregnant or intending to become pregnant during the study, or breastfeeding.
History of clinically significant suicidal thoughts in the prior 12 months.
Life expectancy less than 3 months in the opinion of the investigators
Allergy to any of the components in the investigatory products (eg sunflower oil)
Diagnosis of a malignant condition

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Interventions

DRUGMedicinal Cannabis - C12T12

Participants randomised to receive C12T12 Ruby Balanced Oil will commence with 0.008ml/kg/day (0.1 mg/kg/day THC) in two divided doses, and titrate up in four steps (increase by 0.008ml/kg/day every four days) over 16 days up to a maintenance dose of 0.04ml/kg/day (0.5mg/kg/day THC) in two divided doses, with a ceiling dose of 2ml/day (25mg/day THC) for participants weighing 50kg or more. The maintenance dose will then be continued from day 17 until day 42. Down-titration will occur for 16 days after the end of study visit, in the reverse of the up-titration period.

DRUGMedicinal Cannabis - C20T5

Participants randomised to the C20T5 Ruby CBD Oil will receive a matched volume to the C12T12 arm during the up-titration, maintenance, and down-titration phases.