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

NCT ID: NCT00303823

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2011-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

defined green tea catechin extract

Intervention Type: DIETARY_SUPPLEMENT

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Arm II

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

placebo

Given orally

Intervention Type: DRUG

defined green tea catechin extract

Given orally

Intervention Type: DIETARY_SUPPLEMENT

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

PLCB; Polyphenon E

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Garcia

Role: PRINCIPAL_INVESTIGATOR

Arizona Cancer Center - Tucson

Locations

Arizona Cancer Center - Tucson

Tucson, Arizona, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24388920 (View on PubMed)

Other Identifiers

NCI-2009-00893

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000458081

Identifier Type: -

Identifier Source: secondary_id

HSC 05-40

Identifier Type: -

Identifier Source: secondary_id

05-0144-01

Identifier Type: OTHER

Identifier Source: secondary_id

UAZ03-1-02

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA023074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CN35158

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00893

Identifier Type: -

Identifier Source: org_study_id