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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01060345
First received: January 29, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change in percent staining of CD68 in breast tissue [ Time Frame: Prior to study start and 4-6 weeks after treatment ] [ Designated as safety issue: No ]
  • Change in percent staining of CD31 in breast tissue [ Time Frame: Prior to study start and 4-6 weeks after treatment ] [ Designated as safety issue: No ]
  • Change in percent staining of VEGF in breast tissue [ Time Frame: Prior to study start and after 4-6 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in serum levels of IGF-1 [ Time Frame: Prior to study start and after 4-6 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety of green tea ingestion [ Time Frame: Weekly for duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060345

Contacts
Contact: Jean Gibson, RN 773 834-2167 jgibson@medicine.bsd.uchicago.edu

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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01060345     History of Changes
Other Study ID Numbers: 09-151-B
Study First Received: January 29, 2010
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
DCIS

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

ClinicalTrials.gov processed this record on July 23, 2014