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

Sponsor:	National Cancer Institute (NCI)
Collaborator:	University of Arizona
Information provided by (Responsible Party):	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303823

Purpose

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
Cervical Cancer Precancerous Condition	Dietary Supplement: defined green tea catechin extract Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	A Phase II Trial of Polyphenon E for Cervical Cancer Prevention

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Catechin Epigallocatechin gallate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effect of green tea extract (Polyphenon E) on human papillomavirus (HPV) expression by Digene hybrid capture oncogenic HPV expression before study and 4 months following study completion [ Time Frame: before study and 4 months following study completion ] [ Designated as safety issue: No ]
Effect of this drug on low grade cervical dysplasia by clinical pathology before study and 4 months following study completion [ Time Frame: before study and 4 months following study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Utility of karyometry as an intermediate endpoint biomarker by karyometry average nuclear abnormality before study and 4 months following study completion [ Time Frame: before study and 4 months following study completion ] [ Designated as safety issue: No ]

Enrollment:	208
Study Start Date:	November 2005
Study Completion Date:	November 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.	Dietary Supplement: defined green tea catechin extract Given orally
Placebo Comparator: Arm II Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.	Other: placebo Given orally

Detailed Description:

OBJECTIVES:

Primary

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

Compare the toxicity of green tea extract vs placebo among patients with CIN 1.

Tertiary

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.

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303823

Locations

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Tucson, Arizona, United States, 85258

Sponsors and Collaborators

National Cancer Institute (NCI)

University of Arizona

Investigators

Study Chair:

Francisco A. R. Garcia, MD, MPH

University of Arizona

More Information

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303823 History of Changes
Other Study ID Numbers:	CDR0000458081, P30CA023074, UARIZ-UAZ03-1-02, UARIZ-HSC-0540
Study First Received:	March 15, 2006
Last Updated:	November 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

cervical cancer
cervical intraepithelial neoplasia grade 1
human papilloma virus infection

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Disease
Precancerous Conditions
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Pathologic Processes

Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012