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Trial record 1 of 7 for:    cervical cancer and green tea
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Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303823
First received: March 15, 2006
Last updated: April 23, 2014
Last verified: April 2013

March 15, 2006
April 23, 2014
September 2005
November 2010   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00303823 on ClinicalTrials.gov Archive Site
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Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia
A Phase II Trial of Polyphenon E for Cervical Cancer Prevention

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia Grade 1
  • Human Papilloma Virus Infection
  • Drug: placebo
    Given orally
    Other Name: PLCB
  • Dietary Supplement: defined green tea catechin extract
    Given orally
    Other Name: Polyphenon E
  • Other: laboratory biomarker analysis
    Correlative studies
  • Experimental: Arm I
    Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
    Interventions:
    • Dietary Supplement: defined green tea catechin extract
    • Other: laboratory biomarker analysis
  • Placebo Comparator: Arm II
    Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
    Interventions:
    • Drug: placebo
    • Other: laboratory biomarker analysis
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00303823
NCI-2009-00893, NCI-2009-00893, CDR0000458081, HSC 05-40, 05-0144-01, UAZ03-1-02, P30CA023074, N01CN35158
No
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Francisco Garcia Arizona Cancer Center - Tucson
National Cancer Institute (NCI)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP