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


Phase 2
18 Years
N/A
Not Enrolling
Both
Oral Leukoplakia

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Trial Information

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


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).

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Susan Goodin, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

United States: Institutional Review Board

Study ID:

4383

NCT ID:

NCT00176566

Start Date:

September 2003

Completion Date:

November 2006

Related Keywords:

  • Oral Leukoplakia
  • oral leukoplakia
  • Leukoplakia
  • Leukoplakia, Oral

Name

Location
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901