RecruitingPhase 2ACTRN12619000491167

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


Sponsor

Palliative Care Clinical Studies Collaborative

Enrollment

250 participants

Start Date

Aug 16, 2022

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether tetrahydrocannabinol (THC) — the active ingredient in cannabis — can help improve appetite in people with advanced cancer who have been experiencing reduced appetite (anorexia) for at least two weeks. Loss of appetite is a very common and distressing problem for people with cancer, and few effective treatments exist. Adults aged 18 and over with advanced cancer and poor appetite will be randomly assigned to receive either THC or a placebo (inactive) wafer dissolved under the tongue before meals. The dose starts low and increases over the first week before being maintained for up to three more weeks. All participants will complete questionnaires about their appetite and keep a food diary. You may be eligible if you are 18 or older, have advanced cancer, and have had significantly reduced appetite for at least two weeks. People with severe liver or kidney problems, cognitive impairment, serious psychiatric conditions (including psychosis, schizophrenia, or depression), unstable heart disease, a prior bad reaction to cannabis products, or recent cannabis use are not eligible. This research could provide important evidence to guide doctors in treating one of cancer's most common and debilitating symptoms.

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.

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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 Hy

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)

Campbelltown Hospital - Campbelltown

NSW,SA,VIC, Australia

Concord Repatriation Hospital - Concord

NSW,SA,VIC, Australia

Greenwich Hospital - Greenwich

NSW,SA,VIC, Australia

Bankstown-Lidcombe Hospital - Bankstown

NSW,SA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,SA,VIC, Australia

Calvary Health Care Sydney Ltd - Kogarah

NSW,SA,VIC, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW,SA,VIC, Australia

Braeside Hospital - Prairiewood

NSW,SA,VIC, Australia

Camden Hospital - Camden

NSW,SA,VIC, Australia

Fairfield Hospital - Prairiewood

NSW,SA,VIC, Australia

Footscray Hospital - Footscray

NSW,SA,VIC, Australia

Sunshine Hospital - St Albans

NSW,SA,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,SA,VIC, Australia

Wollongong Hospital - Wollongong

NSW,SA,VIC, Australia

Shoalhaven Hospital - Nowra

NSW,SA,VIC, Australia

Flinders Medical Centre - Bedford Park

NSW,SA,VIC, Australia

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ACTRN12619000491167