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

Oral Leukoplakia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176566
• Other study ID #: 4383
• Secondary ID: CINJ#120301
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 10, 2009
• Start date: September 2003
• Est. completion date: November 2006

Study information

• Verified date: December 2009
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Leukoplakia
• Leukoplakia, Oral
• Oral Leukoplakia

Intervention

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).

Locations

Country	Name	City	State
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

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