Back to resultsA Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
Primary Purpose
Ductal Carcinoma in Situ
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Polyphenon E
Sponsored by
About this trial
This is an interventional prevention trial for Ductal Carcinoma in Situ focused on measuring DCIS
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.
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Women with Ductal Carcinoma in Situ
Arm Description
Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E
Outcomes
Primary Outcome Measures
Percent Change in K167 Staining
Secondary Outcome Measures
Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.
Change in Percent Staining of CD68 in Breast Tissue
Change in Percent Staining of CD31 in Breast Tissue
Change in Percent Staining of VEGF in Breast Tissue
Change in Serum Levels of IGF-1
Safety of Green Tea Ingestion
Number of patients with adverse event.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01060345
Brief Title
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
Official Title
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Drug no longer available
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma in Situ
Keywords
DCIS
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Women with Ductal Carcinoma in Situ
Arm Type
Experimental
Arm Description
Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E
Intervention Type
Drug
Intervention Name(s)
Polyphenon E
Other Intervention Name(s)
Green tea
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent Change in K167 Staining
Time Frame
Prior to starting study and after 4-6 weeks of treatment
Secondary Outcome Measure Information:
Title
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
Title
Change in Percent Staining of CD68 in Breast Tissue
Time Frame
Prior to study start and 4-6 weeks after treatment
Title
Change in Percent Staining of CD31 in Breast Tissue
Time Frame
Prior to study start and 4-6 weeks after treatment
Title
Change in Percent Staining of VEGF in Breast Tissue
Time Frame
Prior to study start and after 4-6 weeks of treatment
Title
Change in Serum Levels of IGF-1
Time Frame
Prior to study start and after 4-6 weeks of treatment
Title
Safety of Green Tea Ingestion
Description
Number of patients with adverse event.
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Jaskowiak, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
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