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

This study has been terminated.
(Transitioned into a national study through ECOG)
Sponsor:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00176566
First received: September 12, 2005
Last updated: December 10, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Oral Leukoplakia
 Drug: Lozenge Intake
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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).
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176566

Locations
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 New Jersey
Investigators
Principal Investigator: Susan Goodin, PharmD University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: Susan Goodin, Pharm.D., The Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT00176566     History of Changes
Other Study ID Numbers: 4383, CINJ#120301
Study First Received: September 12, 2005
Last Updated: December 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
oral leukoplakia

Additional relevant MeSH terms:
Leukoplakia
Leukoplakia, Oral
Precancerous Conditions
Neoplasms
Pathological Conditions, Anatomical
 Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013