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A Pilot Study of Medicinal Cannabis in Paediatric Patients Undergoing Palliative Care for Non-oncological Conditions
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.
Details
| Lead sponsor | Murdoch Childrens Research Institute |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 10 |
| Start date | 2024-02-19 |
| Completion | 2026-12 |
Conditions
- Palliative Care
Interventions
- Medicinal Cannabis - C12T12
- Medicinal Cannabis - C20T5
Primary outcomes
- Study participant recruitment completion time, calculated as the time required to reach a sample size of 10. — From the date of pre-screening the first participant until the tenth participant is randomized, up to 2 years.
The time taken to complete recruitment will be calculated as the number of months from the date of commencing recruitment to the date of randomizing the tenth participant. - Participant withdrawal rate, calculated as the number of participants who withdraw from the trial as a proportion of the total number of participants randomized. — Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)
The number of participants who withdraw from the trial will be calculated as a proportion of the total number of participants randomized. - Study medication tolerability, as indicated by the proportion of participants who tolerate the protocol dosing schedule. — Day 1 to day 43 (date of the end of the maintenance dosing period clinic visit)
The number of participants who adhere to the protocol dosing schedule without medication related protocol deviations, treatment discontinuations or dose modifications will be calculated as a proportion of the total sample for each arm (C12T12 and C20T5). - Participant adherence to the study medication dosing schedule, calculated as the proportion of participants who demonstrate acceptable medication compliance. — Day 58 (date of end of treatment)
Medication compliance will be assessed through pharmacy calculations from returned bottle volumes. Acceptable compliance will fall within the range of 80-120%. The number of participants with acceptable medication compliance will be reported as a proportion of the total sample randomized. - Study visit attendance, calculated as the proportion of visits completed across the study sample. — Screening to day 43 (date of the end of the maintenance dosing period clinic visit)
The number of study visits attended by all participants will be calculated as a proportion of the total possible visits in accordance with the study protocol. - Blood test completion, calculated as the proportion of blood tests completed across the study sample. — Screening to day 43 (date of the end of the maintenance dosing period clinic visit)
The number of study blood tests completed by all participants will be calculated as a proportion of the total possible blood tests in accordance with the study protocol.
Countries
Australia