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

NCT ID: NCT01060345

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-09-30

Brief 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).

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.

Conditions

Ductal Carcinoma in Situ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Women with Ductal Carcinoma in Situ

Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E

Group Type: EXPERIMENTAL

Polyphenon E

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Green tea

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nora Jaskowiak, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

09-151-B

Identifier Type: -

Identifier Source: org_study_id