Oral Leukoplakia Clinical Trial
Official title:
A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
- 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. |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | The Cancer Institute of New Jersey | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
University of Medicine and Dentistry of New Jersey |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia. | 3 years | No | |
Secondary | 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 | No |
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