A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia
- Conditions
- Oral Leukoplakia
- Registration Number
- NCT00176566
- 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 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia. 3 years
- Secondary Outcome Measures
Name Time Method 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 3 years
Trial Locations
- Locations (1)
The Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States