At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 178 enrolled
Drug / intervention
Polyphenon E +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Chemoprevention of Lung Carcinogenesis Using Green Tea: Phase IIb Randomized, Double-Blinded, Placebo Controlled Trial of Green Tea and Polyphenon E in Former Smokers With Chronic Obstructive Lung Disease (COPD)
In Brief
A Phase 2 clinical trial evaluating green tea, Polyphenon E, and 1 other intervention for Lung Cancer Prevention. Completed, enrolled 178 participants across 3 sites.
Detailed Summary
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea or polyphenon E may prevent cancer from forming in former smokers with chronic obstructive pulmonary disease. PURPOSE: This randomized phase II trial is studying how well green tea or polyphenon E work in preventing lung cancer in former smokers with chronic obstructive pulmonary disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer Prevention
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
First PostedAug 2006
Primary CompletionMar 2009
TodayJul 2026
First PostedAug 15, 2006
Enrollment StartMay 1, 2004
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.9 years ago
Interventions
green teadietary
Given orally
Polyphenon Edrug
Given orally
placeboother
Given orally