Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia Grade 1 | — | UNRESOLVED | — |
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| defined green tea catechin extract | Dietary Supplement | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.
- interventionNames
- Dietary Supplement: defined green tea catechin extract
- Other: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
- interventionNames
- Drug: placebo
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGarcia 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. PMID 24388920