Medical Cannabis: Medical cannabis oil three times daily
Study summary
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age =\>18 yrs
* Histologically proven hepatocellular carcinoma
* Non-cirrhosis or Child Pugh A cirrhosis
* Hepatic encephalopathy grade 0 or 1
* Multidisciplinary treatment (MDT)-advised best supportive care for untreatable advanced HCC or patients unable to undergo or declining treatment for advanced HCC.
* Minimal life expectancy of 3 months
* Willing and able to attend follow-up examinations
* Willing to stop active traffic participation or controlling machinery during the study period if applicable
* Signed informed consent
* Language: Dutch or English
Exclusion Criteria:
* Child Pugh B or C cirrhosis
* Hepatic encephalopathy grade 2 or more
* Previous systemic treatment for HCC
* Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
* Use of medicinal cannabis for other purposes
* Contra-indications for medicinal cannabis oil:
* Patients who have experienced a myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or have had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction.
* Patients with known psychotic disorders
* Female patients who are pregnant or lactating
* Patients (men or women) intending to start a family
* Hypersensitivity to cannabinoids or any of the excipients of the cannabis oil
Primary outcome measure(s)
Tumor size — 9 months Tumor size based on RECIST and mRECIST criteria
Trial sites (1)
Facility
City
Region
Status
University Medical Center Groningen
Groningen
Netherlands
Recruiting
More University Medical Center Groningen trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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