Study on Simvastatin for Preventing Liver Cancer in Patients with Liver Cirrhosis
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02968810
This clinical trial is exploring whether simvastatin, a medication, can help prevent liver cancer in people with liver cirrhosis by blocking certain enzymes that cancer cells need to grow.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to see if simvastatin can prevent liver cancer in patients with liver cirrhosis. Simvastatin may work by stopping cancer cells from growing by blocking certain enzymes they need. The study will compare simvastatin to a placebo (a pill with no active medication) to see if there are changes in specific blood markers and liver health over six months.
Description
In this study, participants will be randomly assigned to one of two groups. One group will take simvastatin daily, while the other group will take a placebo. Both groups will have regular blood tests and imaging scans like CT or MRI to monitor their health and any changes in their liver condition. The treatment will last for up to six months unless there are any serious side effects or the disease progresses. After finishing the treatment, participants will have follow-up visits at 30, 60, and 90 days to check their health.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of liver cirrhosis through medical tests or imaging.
- Must be 18 years or older.
- Must be in good general health with a performance status that allows for daily activities.
- Must have certain blood counts and liver function within specified limits.
- Women who can become pregnant must have a negative pregnancy test before joining and agree to use birth control during the study.
- Must be able to understand and sign a consent form and agree to follow the study procedures.
- Must have had an abdominal imaging test within the past 18 months.
Exclusion Criteria
- Cannot have used statin medications before.
- Cannot be taking medications that interact with statins.
- Cannot have allergies or bad reactions to statins.
- Cannot be pregnant or breastfeeding.
- Cannot have had a liver transplant or certain types of liver cancer.
- Cannot have a severe liver disease score (MELD > 20).
- Cannot have uncontrolled health issues like infections or heart problems.
- Cannot have a history of muscle disease or certain cancers.
- Cannot have active HIV infection.
- Cannot have medical conditions that prevent blood draws.
- Cannot have excessive alcohol consumption (more than 5 drinks per day).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Northwestern University | 60611 | Chicago | Illinois |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.