NCT00176566

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Oral Leukoplakia

Interventions

Type	Name	Description
DRUG	Lozenge Intake	of green tea lozenges weighing 6 grams each, containing 0.45 grams of green tea solids eight (8) times daily for 12 weeks to patients with oral leukoplakia compared to the administration of a lozenge that does not contain green tea (i.e. a placebo lozenge).

Timeline

• Start date: 2003-09-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-09-15
• Last updated: 2009-12-11

Locations

1 site across 1 country: United States