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

NCT ID: NCT00176566

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-11-30

Brief Summary

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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

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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

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Oral Leukoplakia

Keywords

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oral leukoplakia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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The Cancer Institute of New Jersey

Principal Investigators

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Susan Goodin, PharmD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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The Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CINJ#120301

Identifier Type: -

Identifier Source: secondary_id

4383

Identifier Type: -

Identifier Source: org_study_id