Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Withdrawn NCT05505539 - Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia Phase 1
Completed NCT03682562 - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Completed NCT04153266 - Oral Epithelial Dysplasia Informational Needs Questionnaire
Completed NCT04712929 - Candida Associated Cytokines in Oral Leukoplakia
Completed NCT03031899 - Comparison or Rose Bengal and Toluidine Blue Staining for Lesion Detection Efficacy
Terminated NCT00571558 - Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia Phase 1
Recruiting NCT06321003 - SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
Not yet recruiting NCT04732741 - Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions
Completed NCT00369174 - Rosiglitazone Maleate in Treating Patients With Oral Leukoplakia Phase 2
Completed NCT00099021 - Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia Phase 2
Not yet recruiting NCT05727761 - Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia Phase 2
Active, not recruiting NCT02581137 - Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion Phase 2
Recruiting NCT05942794 - Identification of Oral Lesions Through an Autofluorescence System N/A
Completed NCT00330382 - Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia Phase 2
Recruiting NCT05237960 - Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia Phase 2
Not yet recruiting NCT06256809 - Analyzing Handprint Patterns to Predict Oral Cancer Risks: A Comparative Study
Completed NCT00951379 - Pioglitazone for Oral Premalignant Lesions Phase 2
Recruiting NCT04251845 - Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia N/A
Terminated NCT04079491 - Intra and Extra Oral Inspection of Oral Mucosa
Recruiting NCT00767442 - Least Invasive Nonlinear Light Microscopy N/A