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A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

NCT01060345 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-04-09

Study results available
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Summary

The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).

Conditions

  • Ductal Carcinoma in Situ

Interventions

DRUG

Polyphenon E

three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Nora Jaskowiak, MD · University of Chicago

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2015-09-30
Completion
2015-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060345 on ClinicalTrials.gov