Trial record 1 of 1 for:
NCT01060345
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
This study is currently recruiting participants.
Verified October 2012 by University of Chicago
Sponsor:
University of Chicago
Information provided by (Responsible Party):
Nora Jaskowiak, University of Chicago
ClinicalTrials.gov Identifier:
NCT01060345
First received: January 29, 2010
Last updated: October 15, 2012
Last verified: October 2012
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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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Camellia sinensis
U.S. FDA Resources
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 2013 |
| Estimated Primary Completion Date: | September 2013 (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
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: | Nora Jaskowiak, Associate Professor of Surgery, 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: | October 15, 2012 |
| 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 May 19, 2013