Medicinal Cannabis for Anorexia in Advanced Cancer
- Conditions
- CancerAnorexiaCancer - Any cancer
- Registration Number
- ACTRN12616000516482
- Lead Sponsor
- niversity of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 13
1) Age 18 years or above;
2) Advanced cancer;
3) Anorexia for at least 2 weeks (defined as numeric rating scale [0 no appetite – 10 best possible appetite] score less than or equal to 4) unresponsive to the optimisation of treatment of causative medical conditions
4) English-speaking (or have an interpreter available);
5) Performance status (Australia-modified Karnofsky Scale score) of 40 or above;
6) Written informed consent.
1) Hepatic impairment (Child’s Stage B)
2) Renal impairment (estimated glomerular filtration rate of <10 mL/min)
3) Cognitive impairment (Montreal Cognitive Assessment (MOCA score<26);
4) Psychiatric disorders (severe depression or anxiety, personality disorder, history of psychosis, schizophrenia, and/or suicidal ideation);
5) Acute delirium or delirium within < 30 days;
6) Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure);
7) Impaired pulmonary function which prohibits use of vaporiser;
8) Prior adverse reaction to botanical cannabis/pharmaceuticals containing cannabinoids;
9) Pregnant, breastfeeding or unwillingness to use oral contraceptives;
10) Substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, benzodiazepines or simulants (excluding caffeine, tobacco).
11) Recent use of cannabis or cannabinoids within < 30 days (based on self-report and urine drug screen at eligibility).
12) Prescribed opioid, benzodiazepine, antidepressant, antipsychotic, corticosteroid, progestin, omega fatty acids and/or dietary supplements, which do not meet the criteria for therapies allowed at eligibility assessment
13) Participation in a clinical trial of another chemical entity.
14) Conditions causing irreversible or blood transfusion dependent anaemia where the volume of blood sampling required for this study is contraindicated in the opinion of the treating clinician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentrations of delta 9-Tetrahydrocannabinol[trough (pre-dose), and at 1, 5, 20, 40 and 60 minutes and 4 hours post inhalation after morning dose at each dose level];Numerical rating scale - Appetite[1, 5, 10, 20, 40 and 60 minutes and 4 hours post inhalation of every dose, and 30 minutes prior to subsequent dose]
- Secondary Outcome Measures
Name Time Method