A study that evaluates the effectiveness of oral combined THC/CBD for people with advanced cancer experiencing a range of symptoms.

Phase 2

Completed

• Conditions: Cancer; Appetite; Fatigue; Nausea; Cancer - Any cancer; Breathlessness; Psychological effects

• Registration Number: ACTRN12619000037101
• Lead Sponsor: Mater Misericordiae Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-14
• Study Completion: 2023-09-19
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:

- have an ESAS TSDS greater than 10 for cancer-related symptoms*
- at least one individual ESAS score greater than 3
- AKPS score >30
- aged >25yrs and above. English speaking (or have interpreter available)
- 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
- have a negative THC urine test
- able to tolerate oral medication
- willing to receive standard palliative care
- comply with trial requirements; agree to attend scheduled clinic appointments, adhere to dose
titration schedule as directed
- agree to use no other cannabis based products for the duration of the trial
- understand it is illegal to drive whilst taking THC containing cannabis products, to take
cannabinoid products outside of Australia or to endorse legal documents whilst taking THC
containing cannabis products
- provide fully informed consent
*physician assessed

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 alanne aminotransferase (ALT) >3.0 time the upper
limit of the institution's normal range; subjects with liver metastasis may have an AST and ALT of
>5.0 times the upper limit of normal
- 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+
- history that drug diversion may be a risk for them or their family/carers
- females who are pregnant or lactating
- concurrent or participation of a new clinical entity with the last 28 days
- treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or
radiation 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 ESAS TSDS [ Assessed at baseline and day 14]