Defined Green Tea Catechin Extract in Preventing Liver Cancer in Participants With Cirrhosis (NCT03278925) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Defined Green Tea Catechin Extract in Preventing Liver Cancer in Participants With Cirrhosis
United States, Puerto Rico14 participantsStarted 2018-08-09
Plain-language summary
This phase I trial studies the side effects and best dose of defined green tea catechin extract and to see how well it works in preventing liver cancer in participants with cirrhosis. Higher levels of the molecule gamma-OHPdG may be found in participants with cirrhosis, which may mean a higher risk of the development of liver cancer. Defined green tea catechin extract may work better to lower levels of gamma-OHPdG and prevent the development of liver cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants with a clinical diagnosis of cirrhosis based on the investigators evaluation, confirmed by ANY ONE of the three following methods to define cirrhosis:
* Established cirrhosis on liver biopsy (Meta-analysis of Histological Data in Viral Hepatitis \[METAVIR\] F4);
* Ultrasound, CT or MRI findings consistent with cirrhosis; nodular appearing liver with or without evidence of portal hypertension
* Transient elastography (FibroScan) with a result \> 12.5 kPa Etiology of cirrhosis will not be considered in determining inclusion in the study
* Participant is able and willing to comply with study procedures, and signed and dated informed consent is obtained
* Participant agrees to consume no more than 2 cups of green tea per day and refrain from taking supplements or foods labeled as containing green tea
* Participant must be aged \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of Polyphenon E in participants \< 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* Platelets \>= 75,000 / uL
* Hemoglobin \>= 8 g/dL
* Serum creatinine OR measured or calculated creatinine clearance within normal institutional limits; glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl) within normal institutional…
What they're measuring
1
Maximum tolerated dose of Polyphenon E
Timeframe: Up to 4 weeks
2
Change in gamma-hydroxy-1,N(2)-propanodeoxyguanosine (gamma-OHPdG) expression in cirrhotic liver