A study investigating safety, dosing and effectiveness of medicinal cannabis for symptom relief for patients with advanced cancer

Phase 1

Completed

• Conditions: Cancer; Fatigue; Pain; Nausea; Shortness of Breath; Psychological effects; Cancer - Any cancer

• Registration Number: ACTRN12618001205224
• Lead Sponsor: The University Of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-18
• Study Completion: 2019-02-04
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Patients with advanced histologically proven cancer (metastatic or locally advanced solid tumours or advanced haematological malignancies) who have been referred or known to the palliative care team who:
- have an ESAS TSDS >10
- at lease one individual ESAS score >3
- AKPS score >30
- aged >25yrs. English speaking (or interpreted available), give fully informed consent
- have a negative pregnancy urine test at eligibility (only if of reproductive potential) and agree to avoid pregnancy during the study and 12
weeks following the last dose of the study drug. Males must agree to avoid fathering a child and to not donate sperm during the study and
for at least 12 weeks following the last dose of the study drug
- able to tolerate oral medication and comply with trial requirements
- agree to use no other cannabis based product
- understand it is illegal to drive a motor vehicle

Exclusion Criteria

Patients with:
- a history of hypersensitivity to any cannabinoid product
- unstable untreated cardiovascular disease (hypertension, ischemic heart disease, congestive cardiac failure)
- severe hepatic impairment (total bilirubin >1.5 times the upper limit of the institution's normal range. Asparate aminotransferase (AST), and Alanine
aminotransferase (ALT) >3.0 time the upper limit. Subjects with liver metastasis may have an AST and ALT >5.0 time the upper limit
- severe renal impairment (eGFR <20mls/min/1.73m2)
- history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, schizophrenia, first degree relative with schizophrenia
and/or suicidal ideation)
- cognitive impairment (SLUMS - St Louis University Mental Status) examination <20/30; known substance use disorder (ASSIST - Alcohol, Smoking and
Substance Involvement Screening Test) examination score <27+; historyof drug diversion may be a risk for them or their family/carers
- females who are pregnant or lactating
- participation in a trial of a new clinical entity with the last 28 days
- treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) within the last 21 days or radioation within the last 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline of total composite ESAS TSDS[Assessed at baseline and that at days 7 and 14. The primary endpoint is day 14 compared to baseline. ]