RecruitingPhase 2ACTRN12619001534178

A phase I/II double-blind, randomised controlled trial assessing effect of medicinal cannabis on quality of life and symptom control in advanced cancer.


Sponsor

Olivia Newton-John Cancer Research Institute

Enrollment

119 participants

Start Date

Sep 25, 2020

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

People living with advanced cancer often experience difficult symptoms such as pain, nausea, anxiety, and poor sleep that can significantly affect their quality of life. Medicinal cannabis has attracted growing interest as a possible way to help manage these symptoms, but we still need properly designed clinical trials to understand how well it works and how safe it is. This Phase 1/2 study is testing a medicinal cannabis oil — taken by mouth — in people with advanced cancer. Two-thirds of participants will receive the active medicinal cannabis oil, and one-third will receive a placebo (an oil that looks the same but contains no cannabis). Doses start once daily and can be increased up to three times daily as needed for symptom relief. The study runs for up to a month, after which participants who received the active drug can continue accessing medicinal cannabis through compassionate access. All participants will provide blood samples and complete questionnaires about their symptoms and quality of life. You may be eligible if you are 18 or older, have been diagnosed with incurable advanced cancer of any type, have a life expectancy of more than 2 months, and are well enough to participate (ECOG score 0–2). You would not be eligible if you have recently started or changed cancer treatment, have used cannabis in the last 30 days, or have significant liver or kidney problems.

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

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)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

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ACTRN12619001534178


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