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

This study has been terminated.
(Drug no longer available)
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: January 29, 2010
Last updated: January 6, 2016
Last verified: January 2016
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).

Condition Intervention
Ductal Carcinoma in Situ
Drug: Polyphenon E

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Percent change in K167 staining [ Time Frame: Prior to starting study and after 4-6 weeks of treatment ]

Secondary Outcome Measures:
  • Decrease in MRI volume and signal enhancement ratio (SER) of the breast lesion from pre- to post-treatment. [ Time Frame: Prior to study start and 4-6 weeks after treatment ]
  • Change in percent staining of CD68 in breast tissue [ Time Frame: Prior to study start and 4-6 weeks after treatment ]
  • Change in percent staining of CD31 in breast tissue [ Time Frame: Prior to study start and 4-6 weeks after treatment ]
  • Change in percent staining of VEGF in breast tissue [ Time Frame: Prior to study start and after 4-6 weeks of treatment ]
  • Change in serum levels of IGF-1 [ Time Frame: Prior to study start and after 4-6 weeks of treatment ]
  • Safety of green tea ingestion [ Time Frame: Weekly for duration of study ]

Enrollment: 32
Study Start Date: May 2010
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women with Ductal Carcinoma in Situ
Women who have been diagnosed with ductal carcinoma in situ (DCIS)
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 Name: Green tea

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01060345

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Nora Jaskowiak, MD University of Chicago
  More Information

Responsible Party: University of Chicago Identifier: NCT01060345     History of Changes
Other Study ID Numbers: 09-151-B
Study First Received: January 29, 2010
Last Updated: January 6, 2016

Keywords provided by University of Chicago:

Additional relevant MeSH terms:
Carcinoma, Ductal
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary processed this record on May 25, 2017