A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
NCT ID: NCT06518434
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2021-04-15
2027-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cannabis oil
Treatment with cannabis oil
Medical Cannabis
Medical cannabis oil three times daily
Interventions
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Medical Cannabis
Medical cannabis oil three times daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Maarten Nijkamp
Principal Investigator
Principal Investigators
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M W Nijkamp, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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DJ A de Groot, MD PhD
Role: CONTACT
Facility Contacts
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Other Identifiers
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201800881
Identifier Type: -
Identifier Source: org_study_id
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