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

• Status: Terminated
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Criteria

• Patients with oral leukoplakia without evidence of active infections in the mouth will be invited to participate in this study.

• Patients must currently consume no more than 3 cups of tea a day,

• not be taking large doses of vitamin A or its derivatives (more than 25,000 units), selenium, or beta-carotene.

• Additionally, patients must not participate in this study if they are allergic to caffeine, have GI ulcers, are pregnant, or have had previous invasive mouth cancer.