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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01060345
Recruitment Status : Terminated (Drug no longer available)
First Posted : February 2, 2010
Last Update Posted : January 7, 2016
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Ductal Carcinoma in Situ 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
Study Start Date : May 2010
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. 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 ]
  2. Change in percent staining of CD68 in breast tissue [ Time Frame: Prior to study start and 4-6 weeks after treatment ]
  3. Change in percent staining of CD31 in breast tissue [ Time Frame: Prior to study start and 4-6 weeks after treatment ]
  4. Change in percent staining of VEGF in breast tissue [ Time Frame: Prior to study start and after 4-6 weeks of treatment ]
  5. Change in serum levels of IGF-1 [ Time Frame: Prior to study start and after 4-6 weeks of treatment ]
  6. Safety of green tea ingestion [ Time Frame: Weekly for duration of study ]

Eligibility Criteria

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01060345     History of Changes
Other Study ID Numbers: 09-151-B
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by University of Chicago:

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ