Tetrahydrocannabinol for cancer-related anorexia

Phase 2

Recruiting

• Conditions: Cancer-related anorexia; Cancer - Any cancer

• Registration Number: ACTRN12619000491167
• Lead Sponsor: Palliative Care Clinical Studies Collaborative

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

•Age greater than or equal to 18 years;
•Advanced cancer;
•Anorexia for at least 2 weeks (defined as numeric rating scale [0 no appetite – 10 best possible appetite] score greater than or equal to 4) unresponsive to the optimisation of treatment of causative medical conditions
•English-speaking (or have an interpreter available);
•Written informed consent.

Exclusion Criteria

•Inability to take medications sublingually
•Severe hepatic impairment (defined as bilirubin greater than or equal to 3 times upper limit of normal; aspartate transaminase and/or alanine transaminase > 5 times upper limit of normal) clinically determined to be due to hepatic impairment
•Renal impairment (estimated glomerular filtration rate of <10 mL/min)
•Cognitive impairment (Montreal Cognitive Assessment (MOCA score<26);
•Psychiatric disorders (severe depression or anxiety, personality disorder, history of psychosis, schizophrenia, and/or suicidal ideation);
•Acute delirium or delirium within < 30 days;
•Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure);
•Prior adverse reaction to botanical cannabis/pharmaceuticals containing cannabinoids;
•Pregnant, breastfeeding or unwillingness to use oral contraceptives;
•Substance use disorder (DSM 5 criteria; to alcohol, opioids, benzodiazepines or simulants (excluding caffeine, tobacco).
•Recent use of cannabis or cannabinoids within < 30 days (based on self-report and urine drug screen at eligibility).
•Prescribed opioid, benzodiazepine, antidepressant, antipsychotic, corticosteroid, progestin, omega fatty acids and/or dietary supplements, which do not meet the therapies allowed at eligibility assessment
•Current participation in a clinical trial of another chemical entity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anorexia-related symptoms and concerns as measured by the 12-item Functional Assessment of anorexia cachexia therapy (FAACT) anorexia cachexia sub-scale [ Baseline, Days 2, 3, 5, Day 7, Day 14 (primary timepoint), Day 21, Day 28. ]