ArticleCancer prevention research (Philadelphia, Pa.)2025
A Phase I Dose-Escalation Study of Polyphenon E in Liver Cirrhosis: Evaluation of Safety and Effect on Liver γ-OHPdG Levels.
Article in Cancer prevention research (Philadelphia, Pa.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Tea and liver fibrosis: a bibliometric analysis of mechanisms, translational challenges, and emerging trends.Frontiers in nutrition · 2026Pooled it
- Anti-cancer effects of plant extracts in head and neck squamous cell carcinoma.Frontiers in pharmacology · 2026Review
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16 authors.
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Abstract
Accumulation of the DNA adduct γ-hydroxy-1,N2-propanodeoxyguanosine (γ-OHPdG) is associated with hepatocellular carcinoma development. Theaphenon E-a green tea polyphenol extract dosed according to mg of epigallocatechin gallate-suppresses the formation of γ-OHPdG and reduces hepatocellular carcinoma development in preclinical models. This study aimed to evaluate the safety of Polyphenon E (Theaphenon E equivalent) and its effect on liver γ-OHPdG levels in patients with cirrhosis. This phase I trial used a 3 + 3 dose-escalation design with five planned Polyphenon E (epigallocatechin gallate) dose levels: 400, 800, 1,200, 1,600, and 2,000 mg daily, administered orally for 24 weeks. Each dose cohort was monitored for "discontinue therapy" criteria for 4 weeks before additional participants were enrolled in the next cohort. Participant liver samples were assessed for γ-OHPdG levels using LC/MS-MS and vibration-controlled transient elastography; endogenous catechin pharmacokinetic data were analyzed. Grade 1 and 2 treatment-related adverse events were observed in 38% of the participants. Liver γ-OHPdG levels declined after treatment in most participants. There was a decrease in the vibration-controlled transient elastography-controlled attenuation parameter in some participants. After Polyphenon E dosing, catechin pharmacokinetic clearance patterns were equivalent for all doses except 1,600 mg. Polyphenon E was well tolerated in participants with cirrhosis at a dose up to and including 1,600 mg/day. Therefore, the recommended starting dose for a phase II trial in a cirrhotic population is 1,200 mg. We observed promising Polyphenon E suppression of liver γ-OHPdG levels. PREVENTION RELEVANCE: In this phase I dose-escalation trial, Polyphenon E was well tolerated in participants with cirrhosis at a dose up to and including 1,600 mg/day. We observed promising Polyphenon E suppression of liver γ-OHPdG levels and recommend 1,200 mg dose for a future phase II trial in a cirrhotic population.
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