A phase I/II double-blind, randomised controlled trial assessing effect of medicinal cannabis on quality of life and symptom control in advanced cancer.
Olivia Newton-John Cancer Research Institute
119 participants
Sep 25, 2020
Interventional
Conditions
Summary
The purpose of this study is to test the impact of medicinal cannabis on quality of life and symptoms in people with advanced cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have advanced cancer and a life expectancy of at least 2 months. Study details Two-thirds of the participants in this study will receive medicinal cannabis, while the other one-third will receive placebo. Both are oils taken by mouth, initially once a day, then increasing to a maximum of 3 times a day. The dose will be increased until symptoms are adequately controlled, then maintained for up to one month. After the trial period is completed, participants will be able to access medicinal cannabis via compassionate access. All participants will provide blood samples and answer questionnaires. We would also like your carer to be involved, if you have one. It is hoped this preliminary study will provide useful information about the risks and benefits of this formulation of medicinal cannabis, and how cannabis is metabolised by the body.
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.
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Interventions
This is a combined Phase 1/2 study. Phase 1 (confirmation of dose finding and participation up to 56 days (up to 28 days screening and 28 days of investigational product administration)) was completed in 2020. Phase 2 is addressing the primary endpoint and will last up to 85 days (up to 28 days' screening, 29 days of investigational product, End of Trial review 28 days after last dose of investigational product). The Investigational Product is an oral liquid (oil) formulation of Medicinal Cannabis or Placebo, with doses between 0.25 mL and 1mL administered one to three times per day, administered orally via syringe, for a maximum of 29 days/1 month. The dose is commenced at 0.25mL once a day, and up-titrated daily based on symptom control and tolerance to a maximum daily dose of 1mL three times a day. Participants increase their dose by 0.25mL at each interval (e.g. morning/afternoon/evening) for symptom control. This is based on their own tolerability of the IP.
Locations(4)
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ACTRN12619001534178