Recruiting

Study on the Effects of Cannabis Oil (Dronabinol and Cannabidiol) for Patients with Untreatable Advanced Liver Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of cannabis oil on patients with advanced liver cancer, specifically a type called hepatocellular carcinoma. The treatment being tested is a special formulation of cannabis oil that contains 10% dronabinol and 5% cannabidiol. These substances are delivered as an oromucosal spray, which means they are sprayed into the mouth where they can be absorbed through the lining of the mouth.

The purpose of the study is to explore whether this cannabis oil can have an anti-cancer effect in patients whose liver cancer cannot be treated with standard therapies. Participants in the study will use the cannabis oil for a period of up to nine months. During this time, they will have regular check-ups to monitor their health and the effects of the treatment. The study aims to see if the cannabis oil can help reduce the size of the cancer or slow its growth.

Throughout the study, participants will be asked to attend follow-up examinations to track their progress. The study will assess the response of the cancer to the treatment using imaging techniques at the end of the nine-month period. This research is important as it seeks to find new ways to help patients with advanced liver cancer who have limited treatment options.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your willingness to participate.
You must meet certain criteria, such as being 18 years or older, speaking Dutch or English, and having a confirmed diagnosis of advanced liver cancer that cannot be treated with standard methods.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status. This may include physical examinations and imaging tests to establish a baseline for your condition.
Step 3
Medication administration
You will begin taking the study medication, which is cannabis oil containing THC 10% and CBD 5%.
The medication is administered sublingually, meaning it is placed under the tongue for absorption.
The dosage and frequency will be determined by the study team and will be explained to you in detail.
Step 4
Regular follow-up visits
You will attend regular follow-up visits to monitor your response to the treatment. These visits will include physical exams and imaging tests to assess any changes in your condition.
It is important to attend all scheduled visits to ensure accurate monitoring of your health.
Step 5
End of study assessment
At the end of the study period, a final assessment will be conducted. This will involve similar tests and evaluations as the initial assessment to determine the overall effect of the treatment.
The study aims to assess the response rate of the treatment at 9 months after starting the cannabis oil.

Who can join the trial?

10 criteria

Must be at least 18 years old.
Must speak either Dutch or English.
Must have a diagnosis of hepatocellular carcinoma, which is a type of liver cancer, confirmed by a medical test.
Must not have liver damage known as cirrhosis, or if they do, it should be classified as Child Pugh A, which is a mild form.
Must have hepatic encephalopathy at grade 0 or 1, which means little to no impact on brain function due to liver disease.
Must have been advised by a team of doctors to receive the best supportive care for advanced liver cancer that cannot be treated, or must be unable or unwilling to undergo treatment for advanced liver cancer.
Must have a minimum life expectancy of 3 months.
Must be willing and able to attend follow-up examinations.
Must be willing to stop driving or operating machinery during the study period if necessary.
Must have signed an informed consent form, which means they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

Patients who do not have untreatable hepatocellular carcinoma cannot participate. Hepatocellular carcinoma is a type of liver cancer.
Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.

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Verified sites

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Universitair Medisch Centrum Groningen
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Groningen, The Netherlands

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Investigated drugs

Cannabis Oil is being studied for its potential effects on liver cancer that cannot be treated with standard methods. This oil contains two main components: THC and CBD. THC is known for its ability to create a feeling of being "high," but it may also help reduce pain and inflammation. CBD does not cause a high and is often used for its calming effects. In this study, researchers are looking to see if the combination of THC and CBD in cannabis oil can help slow down or stop the growth of liver cancer cells.

What is already known about the treatment

Cannabis Oil (THC 10% / CBD 5%) – This medication is administered orally in the form of oil and is currently being studied for its potential benefits in treating patients with advanced liver cancer that cannot be treated with standard methods. In medical literature, cannabis oil is being explored for its possible anti-tumor effects, particularly in this specific type of cancer. The main therapeutic indication for this study is untreatable advanced hepatocellular carcinoma, a severe form of liver cancer. At the molecular level, the active compounds in cannabis oil, THC and CBD, are believed to interact with the body's endocannabinoid system, which may help in reducing tumor growth. Cannabis oil is classified pharmacologically as a cannabinoid, which is a type of compound found in the cannabis plant.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, particularly in individuals with cirrhosis due to hepatitis B or C infection, or alcohol abuse. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As the tumor enlarges, it may cause symptoms such as abdominal pain, weight loss, and jaundice. Over time, the cancer can invade blood vessels and spread to nearby organs or distant sites. The progression of hepatocellular carcinoma can vary, with some tumors growing slowly and others advancing more rapidly.