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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176566
Recruitment Status : Terminated (Transitioned into a national study through ECOG)
First Posted : September 15, 2005
Last Update Posted : December 11, 2009
Information provided by:
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Oral Leukoplakia Drug: Lozenge Intake Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia
Study Start Date : September 2003
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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).

Primary Outcome Measures :
  1. To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176566

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United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
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Principal Investigator: Susan Goodin, PharmD Rutgers, The State University of New Jersey

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Responsible Party: Susan Goodin, Pharm.D., The Cancer Institute of New Jersey Identifier: NCT00176566     History of Changes
Other Study ID Numbers: 4383
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: December 2009
Keywords provided by Rutgers, The State University of New Jersey:
oral leukoplakia
Additional relevant MeSH terms:
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Leukoplakia, Oral
Precancerous Conditions
Pathological Conditions, Anatomical
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases