A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients

NCT ID: NCT06518434

Last Updated: 2024-07-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2027-04-15

Brief Summary

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to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria

Detailed Description

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Conditions

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Hepatocellular Carcinoma Cannabis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cannabis oil

Treatment with cannabis oil

Group Type EXPERIMENTAL

Medical Cannabis

Intervention Type DRUG

Medical cannabis oil three times daily

Interventions

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Medical Cannabis

Medical cannabis oil three times daily

Intervention Type DRUG

Other Intervention Names

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Cannabis oil containing 10% delta-9-tetrahydrocannabinol (THC) and 5% cannabidiol (CBD)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Maarten Nijkamp

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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M W Nijkamp, MD PhD

Role: CONTACT

+31625649985

DJ A de Groot, MD PhD

Role: CONTACT

Facility Contacts

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Maarten W Nijkamp, MD PhD

Role: primary

+31625649985

Other Identifiers

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201800881

Identifier Type: -

Identifier Source: org_study_id

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