Medicinal Cannabis for symptom burden in children with advanced cancer

Phase 2

Recruiting

• Conditions: Advanced cancer; Cancer - Children's - Brain; Cancer - Children's - Leukaemia & Lymphoma; Cancer - Children's - Other

• Registration Number: ACTRN12622000037707
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-17
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Aged 6 months to 21 years
2. Have advanced cancer (metastatic or locally advanced solid tumours, brain tumours or advanced hematological malignancies)
3. Have been referred to, or are known to the paediatric palliative care service
4. Are symptomatic according to the MSAS Scale
5. Have a performance status of =>30

Exclusion Criteria

1. History of unstable, untreated cardiovascular disease
2. Severe hepatic or renal impairment
3. History of psychiatric disorder
4. Known substance use disorder
5. History suggesting drug diversion may occur
6. Participation in a trial of an investigational agent within the last 28 days
7. Pregnancy
8. Breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in total symptom burden from baseline to maintenance phase as measured by the 32 item Memorial Symptom Assessment Scale (MSAS) Global Distress Index. [ Weeks -2 and -1 (baseline), weeks 1 and 2 (titration phase) and weeks 3, 4, 5 and 6 (maintenance phase).]