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

Ductal Carcinoma in Situ Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01060345
• Other study ID #: 09-151-B
• Status: Terminated
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: September 2015

Study information

• Verified date: March 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in K167 Staining		Prior to starting study and after 4-6 weeks of treatment
Secondary	Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.		Prior to study start and 4-6 weeks after treatment
Secondary	Change in Percent Staining of CD68 in Breast Tissue		Prior to study start and 4-6 weeks after treatment
Secondary	Change in Percent Staining of CD31 in Breast Tissue		Prior to study start and 4-6 weeks after treatment
Secondary	Change in Percent Staining of VEGF in Breast Tissue		Prior to study start and after 4-6 weeks of treatment
Secondary	Change in Serum Levels of IGF-1		Prior to study start and after 4-6 weeks of treatment
Secondary	Safety of Green Tea Ingestion	Number of patients with adverse event.	6 weeks