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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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).
Sponsor: University of Medicine and Dentistry of New Jersey

Current Primary Outcome: To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia. [ Time Frame: 3 years ]

Original Primary Outcome: To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia.

Current Secondary Outcome: Additionally, we will correlate the changes in oral leukoplakia with levels of tea polyphenols in saliva and in biopsied lesions; DNA content in leukoplakia cells obtained from buccal scrapings; and proliferation index, apoptotic index, and expression of [ Time Frame: 3 years ]

Original Secondary Outcome: Additionally, we will correlate the changes in oral leukoplakia with levels of tea polyphenols in saliva and in biopsied lesions; DNA content in leukoplakia cells obtained from buccal scrapings; and proliferation index, apoptotic index, and expression of

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: September 12, 2005
Date Started: September 2003
Date Completion:
Last Updated: December 10, 2009
Last Verified: December 2009