Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia
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ClinicalTrials.gov Identifier: NCT00303823 |
Recruitment Status :
Completed
First Posted : March 17, 2006
Results First Posted : August 17, 2012
Last Update Posted : May 5, 2015
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Condition or disease | Intervention/treatment | Phase |
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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 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Phase II Trial of Polyphenon E for Cervical Cancer Prevention |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | February 2011 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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)
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303823
United States, Arizona | |
Arizona Cancer Center - Tucson | |
Tucson, Arizona, United States, 85724-5024 |
Principal Investigator: | Francisco Garcia | Arizona Cancer Center - Tucson |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303823 |
Other Study ID Numbers: |
NCI-2009-00893 NCI-2009-00893 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000458081 HSC 05-40 05-0144-01 ( Other Identifier: Arizona Cancer Center - Tucson ) UAZ03-1-02 ( Other Identifier: DCP ) P30CA023074 ( U.S. NIH Grant/Contract ) N01CN35158 ( U.S. NIH Grant/Contract ) |
First Posted: | March 17, 2006 Key Record Dates |
Results First Posted: | August 17, 2012 |
Last Update Posted: | May 5, 2015 |
Last Verified: | April 2013 |
Papillomavirus Infections Uterine Cervical Neoplasms Neoplasms Carcinoma in Situ Papilloma Cervical Intraepithelial Neoplasia Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Virus Diseases Infections Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell DNA Virus Infections Tumor Virus Infections Epigallocatechin gallate Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Neuroprotective Agents |