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:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176566
First received: September 12, 2005
Last updated: December 10, 2009
Last verified: December 2009

September 12, 2005
December 10, 2009
September 2003
November 2006   (final data collection date for primary outcome measure)
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 ]
To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia.
Complete list of historical versions of study NCT00176566 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia
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.

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).

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Oral Leukoplakia
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).
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
November 2006
November 2006   (final data collection date for primary outcome measure)
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176566
4383, CINJ#120301
Not Provided
Susan Goodin, Pharm.D., The Cancer Institute of New Jersey
University of Medicine and Dentistry New Jersey
Not Provided
Principal Investigator: Susan Goodin, PharmD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP