A Phase I Dose-Escalation Study of Polyphenon E in Liver Cirrhosis: Evaluation of Safety and Effect on Liver γ-OHPdG Levels
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.
Authors
- Fung‐Lung Chung
- Stephen S. Hecht (ORCID: https://orcid.org/0000-0001-7228-1356)
- Aiwu Ruth He (ORCID: https://orcid.org/0000-0002-2104-0816)
- Luz M. Rodriguez (ORCID: https://orcid.org/0000-0002-2119-6124)
- Shengmin Sang (ORCID: https://orcid.org/0000-0002-5005-3616)
- Kelly A. Benante (ORCID: https://orcid.org/0000-0002-4014-6560)
- Ellen Richmond (ORCID: https://orcid.org/0000-0002-5855-5047)
- Marcia Cruz‐Correa (ORCID: https://orcid.org/0000-0001-8147-7457)
- Seema A. Khan (ORCID: https://orcid.org/0000-0002-6307-2023)
- Tia Schering
- Latifa A. Bazzi (ORCID: https://orcid.org/0000-0001-6886-3492)
- Shuwei Zhang (ORCID: https://orcid.org/0000-0002-4634-2650)
- Coleman I. Smith (ORCID: https://orcid.org/0000-0002-8932-5623)
- Ranajit Chakraborty (ORCID: https://orcid.org/0000-0001-9576-916X)
- Guang Cheng
- Masha Kocherginsky (ORCID: https://orcid.org/0000-0002-3510-9562)
Institutions
- Northwestern University (US)
- University of Minnesota (US)
- University of Puerto Rico, Medical Sciences Campus (PR)
- Georgetown University (US)
- University of Puerto Rico System (PR)
- Georgetown University Medical Center (US)
- Walter Reed National Military Medical Center (US)
- MedStar Georgetown University Hospital (US)
- North Carolina Agricultural and Technical State University (US)
- University of Minnesota Medical Center (US)
- National Cancer Institute (US)
- Vince Lombardi Cancer Clinic (US)
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
- Georgetown Lombardi Comprehensive Cancer Center
Publication Details
- Journal
- Cancer Prevention Research
- Published
- 2025-06-27
- DOI
- https://doi.org/10.1158/1940-6207.capr-24-0526
- Primary Topic
- Tea Polyphenols and Effects
- Type
- article
- Field-Weighted Citation Impact
- 0.00