Tetrahydrocannabinol for cancer-related anorexia
Phase IIb double-blind, placebo-controlled study of sublingual delta-9-tetrahydrocannabinol (Hypera®) for anorexia in people with advanced cancer
Palliative Care Clinical Studies Collaborative
250 participants
Aug 16, 2022
Interventional
Conditions
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
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
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® 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.
Locations(16)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12619000491167