Ductal Carcinoma in Situ
Conditions
Keywords
DCIS
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.
Interventions
DRUGPolyphenon 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
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in K167 Staining | Prior to starting study and after 4-6 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change in Percent Staining of CD68 in Breast Tissue | Prior to study start and 4-6 weeks after treatment | — |
| Change in Percent Staining of CD31 in Breast Tissue | Prior to study start and 4-6 weeks after treatment | — |
| Change in Percent Staining of VEGF in Breast Tissue | Prior to study start and after 4-6 weeks of treatment | — |
| Change in Serum Levels of IGF-1 | Prior to study start and after 4-6 weeks of treatment | — |
| Safety of Green Tea Ingestion | 6 weeks | Number of patients with adverse event. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Women With Ductal Carcinoma in Situ Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E
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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Women With Ductal Carcinoma in Situ |
|---|---|
| Age, Continuous | 56.8 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 6 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Percent Change in K167 Staining
Time frame: Prior to starting study and after 4-6 weeks of treatment
Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply
Secondary
Change in Percent Staining of CD31 in Breast Tissue
Time frame: Prior to study start and 4-6 weeks after treatment
Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply
Secondary
Change in Percent Staining of CD68 in Breast Tissue
Time frame: Prior to study start and 4-6 weeks after treatment
Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply
Secondary
Change in Percent Staining of VEGF in Breast Tissue
Time frame: Prior to study start and after 4-6 weeks of treatment
Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply
Secondary
Change in Serum Levels of IGF-1
Time frame: Prior to study start and after 4-6 weeks of treatment
Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply
Secondary
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
Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply
Secondary
Safety of Green Tea Ingestion
Number of patients with adverse event.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Women With Ductal Carcinoma in Situ | Safety of Green Tea Ingestion | 6 Participants |