None listed
Conditions
Brief summary
The purpose of this study is to evaluate if tetrahydrocannabinol (THC) can improve anorexia in people with cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have advanced cancer, and have experienced reduced appetite (anorexia) for at least 2 weeks Study details Participants will be randomised by chance into two groups. Both groups will take an increasing dose of sublingual wafers before meals for one week before sustaining the high dose for up to 3 weeks. In one group, the wafers will contain THC and in the other group the wafers will be the same except not contain any THC. All participants in this study will complete a series of questionnaires and complete a food diary. It is hoped this research will provide some evidence about the utility of THC for appetite improvement in this population
Interventions
Hypera®, (iX Biopharma, Australia), an sublingual wafer containing winterized THC Oil and less than 2% of other minor cannabinoids. Dose titration will occur day 1 – 7; they will receive sublingual Hypera® 5 mg before dinner on days one and two, titrated up to 5 mg three times a day, 1-2 hours before meals. There will be allowance for dose reduction if intolerable adverse effects to the prior dose level, which will then be carried to maintenance phase. The maintenance phase will be from day 8-14
Hypera®, (iX Biopharma, Australia), an sublingual wafer containing winterized THC Oil and less than 2% of other minor cannabinoids. Dose titration will occur day 1 – 7; they will receive sublingual Hypera® 5 mg before dinner on days one and two, titrated up to 5 mg three times a day, 1-2 hours before meals. There will be allowance for dose reduction if intolerable adverse effects to the prior dose level, which will then be carried to maintenance phase. The maintenance phase will be from day 8-14 Hypera® 5 mg tds before meals (or lower dose if required). The primary outcome will be measured on day 14. Participants without toxicity will then enter the two-week extension phase (day 15-28), with weekly assessments for efficacy and toxicity. At the end of the study participants will not continue on the study medication and will have a weaning phase over 4 days. There is a weekly, follow-up period of 28 days.
Sponsors
Palliative Care Clinical Studies Collaborative
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed