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Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303823 |
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea extract may stop cervical cancer from forming in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. It is not yet known whether green tea extract is more effective than a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia.
PURPOSE: This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia.
Condition | Intervention | Phase |
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Cervical Cancer Precancerous/Nonmalignant Condition |
Dietary Supplement: defined green tea catechin extract Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase II Trial of Polyphenon E for Cervical Cancer Prevention |
Estimated Enrollment: | 176 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
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Dietary Supplement: defined green tea catechin extract
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
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Other: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At increased risk for developing cervical cancer due to ≥ 1 of the following criteria (documented 6-12 months ago)*:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting |
Tucson, Arizona, United States, 85724-5024 | |
Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 | |
Veterans Affairs Medical Center - Tucson | Recruiting |
Tucson, Arizona, United States, 85723 | |
Contact: Francisco A. Garcia 520-626-8539 | |
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Recruiting |
Tucson, Arizona, United States, 85258 | |
Contact: Francisco A. Garcia 520-626-8539 |
Study Chair: | Francisco A. R. Garcia, MD, MPH | University of Arizona |
Responsible Party: | Arizona Cancer Center at University of Arizona Health Sciences Center ( David Samuel Alberts ) |
Study ID Numbers: | CDR0000458081, UARIZ-UAZ03-1-02, UARIZ-HSC-0540 |
Study First Received: | March 15, 2006 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00303823 History of Changes |
Health Authority: | Unspecified |
cervical cancer cervical intraepithelial neoplasia grade 1 human papilloma virus infection |
Virus Diseases Epigallocatechin gallate Precancerous Conditions Carcinoma in Situ Papillomavirus Infections |
Papilloma Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Neoplasms Neoplasms by Histologic Type Precancerous Conditions Carcinoma in Situ |
Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |