A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia

Status Terminated

Clinical Trial Summary

You have been asked to participate in this research study because you have or may have oral leukoplakia. Oral leukoplakia is described as a white patch or plaque on the oral mucosa (mouth) that will not rub off and cannot be removed by scraping, reversed by elimination of obvious irritants (things that cause redness and/or swelling) such as dentures (artificial replacment for missing teeth), or lesions as described that are diagnosed by your dentist.

Clinical Trial Description

Since oral leukoplakia may precede the development of cancer, using agents that may prevent cancer, called chemoprevention, may be useful. The purpose of this study is to determine whether taking a green tea preparation may have effects on your leukoplakia. It is hoped that these effects may reduce the subsequent risk of cancer in or around the area of leukoplakia. To assess for these effects, samples of the lining of your mouth will be obtained, and they will be analyzed looking for certain features (biomarkers). ;

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00176566
Study type	Interventional
Source	Rutgers, The State University of New Jersey
Contact
Status	Terminated
Phase	Phase 2
Start date	September 2003
Completion date	November 2006

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See also
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