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

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

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).

Study Overview

• Status: Terminated
• Conditions: Ductal Carcinoma in Situ
• Intervention / Treatment: Drug: Polyphenon E

Detailed Description

Many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. Some studies have found that Asian women who drink many cups of green tea have lower rates of breast cancer. Green tea may have an effect on proliferative and inflammatory pathways. Women with ductal carcinoma in situ (DCIS) have been found to have inflammation in the breast tissue surrounding DCIS lesions. Inflammatory pathways are being studied for a possible link to cancer. This study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume.
• Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis.
• Age >18 years.
• ECOG performance status <2 (Karnofsky >60%)
• Life expectancy of greater than 12 months.
• Normal organ and marrow function as defined below:
• leukocytes >3,000/mcL
• absolute neutrophil count >1,500/mcL
• platelets >100,000/mcL
• total bilirubin within normal institutional limits
• AST(SGOT) & ALT(SGPT)within normal institutional limits
• creatinine <1.5 times institutional upper limit of normal or creatinine clearance >60 mL/min/1.73 m2
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Pregnancy
• Patients who have undergone prior excisional biopsy for DCIS.
• Patients who are unable to undergo MRI due to claustrophobia or other reason.
• Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study.
• Patients receiving any other chemotherapy or investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea.
• Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Women with Ductal Carcinoma in Situ; Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E	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; Other Names: Green tea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change in K167 Staining	Prior to starting study and after 4-6 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.		Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of CD68 in Breast Tissue		Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of CD31 in Breast Tissue		Prior to study start and 4-6 weeks after treatment
Change in Percent Staining of VEGF in Breast Tissue		Prior to study start and after 4-6 weeks of treatment
Change in Serum Levels of IGF-1		Prior to study start and after 4-6 weeks of treatment
Safety of Green Tea Ingestion	Number of patients with adverse event.	6 weeks

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Nora Jaskowiak, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: January 29, 2010
• First Submitted That Met QC Criteria: January 29, 2010
• First Posted (ESTIMATE): February 2, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: DCIS
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Carcinoma; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: 09-151-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No