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Trial Title:
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
NCT ID:
NCT06518434
Condition:
Hepatocellular Carcinoma
Cannabis
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Marijuana Abuse
Dronabinol
Cannabidiol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Medical Cannabis
Description:
Medical cannabis oil three times daily
Arm group label:
Cannabis oil
Other name:
Cannabis oil containing 10% delta-9-tetrahydrocannabinol (THC) and 5% cannabidiol (CBD)
Summary:
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC
patients based on mRECIST and RECIST criteria
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Maarten W Nijkamp, MD PhD
Phone:
+31625649985
Email:
m.w.nijkamp@umcg.nl
Start date:
April 15, 2021
Completion date:
April 15, 2027
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06518434
