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

NCT00176566 | Terminated Phase 2

• 2 other identifiers: 4383CINJ#120301
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Leukoplakia

Keywords

oral leukoplakia

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (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

  3 years

Interventions

Lozenge Intake DRUG

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Leukoplakia, Oral

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Goodin, PharmD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: December 11, 2009

Record last verified: 2009-12

Locations

US (1)