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

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. 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.

Condition	Intervention	Phase
Cervical Cancer Cervical Intraepithelial Neoplasia Grade 1 Human Papilloma Virus Infection	Drug: placebo Dietary Supplement: defined green tea catechin extract Other: laboratory biomarker analysis	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study 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: Camellia sinensis

Genetic and Rare Diseases Information Center resources: Cervical Intraepithelial Neoplasia

U.S. FDA Resources

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

Primary Outcome Measures:

Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia [ Time Frame: 4 months ] [ Designated as safety issue: No ]
No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer [ Time Frame: 4 months ] [ Designated as safety issue: No ]


Enrollment:	98
Study Start Date:	September 2005
Study Completion Date:	November 2010
Primary Completion Date:	November 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 Other Name: Polyphenon E Other: laboratory biomarker analysis Correlative studies
Placebo Comparator: Arm II Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.	Drug: placebo Given orally Other Name: PLCB Other: laboratory biomarker analysis Correlative studies

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.

Eligibility


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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, Arizona
Arizona Cancer Center - Tucson
Tucson, Arizona, United States, 85724-5024

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Francisco Garcia	Arizona Cancer Center - Tucson

More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Garcia FA, Cornelison T, Nuño 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.


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303823 History of Changes
Other Study ID Numbers:	NCI-2009-00893, NCI-2009-00893, CDR0000458081, HSC 05-40, 05-0144-01, UAZ03-1-02, P30CA023074, N01CN35158
Study First Received:	March 15, 2006
Results First Received:	July 13, 2012
Last Updated:	April 23, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Carcinoma in Situ Cervical Intraepithelial Neoplasia Papillomavirus Infections Uterine Cervical Dysplasia Uterine Cervical Neoplasms Carcinoma DNA Virus Infections Genital Diseases, Female Genital Neoplasms, Female Neoplasms	Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Precancerous Conditions Tumor Virus Infections Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015