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Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

Primary Purpose

Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 1, Human Papilloma Virus Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
placebo
defined green tea catechin extract
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed cervical intraepithelial neoplasia 1 (CIN 1) AND oncogenic human papillomavirus (HPV) positivity At increased risk for developing cervical cancer due to >= 1 of the following criteria (documented 6-12 months ago)*: Positive oncogenic HPV on DNA hybrid capture Low-grade squamous intraepithelial lesion cytology Histopathologically documented CIN 1 on cervical biopsy [Note: *Patients must now have current CIN 1 by histology or colposcopy AND HPV positivity] Cervical dysplasia by colposcopy OR positive biopsy No invasive cervical cancer or high-grade intraepithelial neoplasia on cervical biopsy or endocervical curettage ECOG performance status < 2 Total bilirubin < 2 times upper limit of normal (ULN) AST < 2 times ULN ALT normal Creatinine < 2.0 mg/dL Able and willing to return to clinic for study visits once every 4 weeks for the duration of the study No history of allergic reaction to tea or related dietary products No HIV positive patients (or AIDS/HIV-associated complex) No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection other than HPV Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with study requirements No history of any cancer except nonmelanoma skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No regular intake of 6 or more servings of tea per week within 1 month prior to study entry No treatment for genital condyloma within 30 days prior to study entry No prior pelvic irradiation No concurrent tea (green, black, or oolong) or tea-derived products No other concurrent investigational agents

Sites / Locations

  • Arizona Cancer Center - Tucson

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.

Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.

Outcomes

Primary Outcome Measures

Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease
Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia
No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia
Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer

Secondary Outcome Measures

Full Information

First Posted
March 15, 2006
Last Updated
April 14, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00303823
Brief Title
Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia
Official Title
A Phase II Trial of Polyphenon E for Cervical Cancer Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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.
Detailed Description
PRIMARY OBJECTIVES: I. Assess the effect of green tea extract (Polyphenon E®) in patients with human papillomavirus (HPV) expression and low-grade cervical intraepithelial neoplasia (CIN 1) in a pre- and post-treatment setting. SECONDARY OBJECTIVES: I. Compare the toxicity of green tea extract vs placebo among patients with CIN 1. TERTIARY OBJECTIVES: I. Evaluate the utility of karyometry as an intermediate endpoint biomarker for cervical chemoprevention studies. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral green tea extract (Polyphenon E®) once daily for 16 weeks in the absence of unacceptable toxicity. ARM II: Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity. After completion of study treatment, patients are followed for 2 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 1, Human Papilloma Virus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given orally
Intervention Type
Dietary Supplement
Intervention Name(s)
defined green tea catechin extract
Other Intervention Name(s)
Polyphenon E
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease
Time Frame
4 months
Title
Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia
Time Frame
4 months
Title
No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia
Time Frame
4 months
Title
Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed cervical intraepithelial neoplasia 1 (CIN 1) AND oncogenic human papillomavirus (HPV) positivity At increased risk for developing cervical cancer due to >= 1 of the following criteria (documented 6-12 months ago)*: Positive oncogenic HPV on DNA hybrid capture Low-grade squamous intraepithelial lesion cytology Histopathologically documented CIN 1 on cervical biopsy [Note: *Patients must now have current CIN 1 by histology or colposcopy AND HPV positivity] Cervical dysplasia by colposcopy OR positive biopsy No invasive cervical cancer or high-grade intraepithelial neoplasia on cervical biopsy or endocervical curettage ECOG performance status < 2 Total bilirubin < 2 times upper limit of normal (ULN) AST < 2 times ULN ALT normal Creatinine < 2.0 mg/dL Able and willing to return to clinic for study visits once every 4 weeks for the duration of the study No history of allergic reaction to tea or related dietary products No HIV positive patients (or AIDS/HIV-associated complex) No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection other than HPV Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness/social situation that would limit compliance with study requirements No history of any cancer except nonmelanoma skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No regular intake of 6 or more servings of tea per week within 1 month prior to study entry No treatment for genital condyloma within 30 days prior to study entry No prior pelvic irradiation No concurrent tea (green, black, or oolong) or tea-derived products No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Garcia
Organizational Affiliation
Arizona Cancer Center - Tucson
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Cancer Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24388920
Citation
Garcia FA, Cornelison T, Nuno T, Greenspan DL, Byron JW, Hsu CH, Alberts DS, Chow HH. Results of a phase II randomized, double-blind, placebo-controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia. Gynecol Oncol. 2014 Feb;132(2):377-82. doi: 10.1016/j.ygyno.2013.12.034. Epub 2014 Jan 2.
Results Reference
derived

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Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

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