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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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ClinicalTrials.gov Identifier: NCT00303823
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : August 17, 2012
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment 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

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.


Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease [ Time Frame: 4 months ]
  2. Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia [ Time Frame: 4 months ]
  3. No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia [ Time Frame: 4 months ]
  4. Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

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


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303823     History of Changes
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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Virus Diseases
Carcinoma in Situ
Papilloma
Cervical Intraepithelial Neoplasia
Papillomavirus Infections
Uterine Cervical Dysplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
DNA Virus Infections
Tumor Virus Infections
Precancerous Conditions
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents