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Cervical CancerPhase 2NCT00303823

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

A Phase 2 study testing defined green tea catechin extract and laboratory biomarker analysis in people with Cervical Cancer and Cervical Intraepithelial Neoplasia Grade 1, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
defined green tea catechin extract and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
1 siteUnited States
Study dates
Sep 2005to Feb 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 30Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arizona Cancer Center - Tucson

    Tucson, Arizona, 85724-5024

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

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

TERTIARY OBJECTIVES:

  1. 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.

Being tested
placebo, defined green tea catechin extract, laboratory biomarker analysis
Medical subject headings
Uterine Cervical Neoplasms, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    Also called PLCB

    Given orally

  • defined green tea catechin extractDietary supplement

    Also called Polyphenon E

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00303823
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
Receives: Dietary Supplement: defined green tea catechin extract; Other: laboratory biomarker analysis
Arm IIPlacebo comparatorPatients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
Receives: Drug: placebo; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease

    Measured: 4 months

  2. Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia

    Measured: 4 months

  3. No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia

    Measured: 4 months

  4. Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionNov 2010
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303823
Sponsor's protocol ID
NCI-2009-00893
Other IDs
NCI-2009-00893, CDR0000458081, HSC 05-40, 05-0144-01, UAZ03-1-02, P30CA023074, N01CN35158
Status last verified
Apr 2013
First submitted
15 Mar 2006
Last updated
5 May 2015
Data monitoring committee
No

Publications

  • Garcia FA, Cornelison T, Nuno 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.

    PubMed 24388920

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing defined green tea catechin extract and laboratory biomarker analysis in people with Cervical Cancer and Cervical Intraepithelial Neoplasia Grade 1, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303823, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.

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