Ductal Carcinoma in Situ
Conditions
Keywords
Black Cohosh, Ductal Carcinoma in situ, Breast Cancer
Brief summary
The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a pre-operative setting.
Detailed description
The overarching hypothesis of our research is that black cohosh has potential to be a well-tolerated, effective agent for the treatment of early breast cancer. This pilot study represents a first step in exploring this hypothesis by demonstrating preliminary evidence of specific anti-tumor effect of black cohosh on areas of ductal carcinoma in situ (DCIS) in the breast.
Interventions
DIETARY_SUPPLEMENTBlack cohosh
Remifemin 20 mg tablet orally twice per day x 4 weeks
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* A patient/subject is eligible for enrollment if all of the following inclusion criteria are met: 1. Pre- and post-menopausal women ≥ 18 years of age newly diagnosed with DCIS histologically confirmed on breast core biopsy 2. Ability to understand and the willingness to sign a written informed consent document 3. ECOG performance status 0-1 4. Life expectancy \>12 months 5. Willing to schedule definitive resection of DCIS 4 weeks +/- 1 week after study enrollment 6. Original breast core biopsy specimen available for pathologic review and staining by Yale School of Medicine Department of Pathology
Exclusion criteria
* A patient /subject will not be eligible for this study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure change in size of DCIS on routine imaging | 4 weeks | 1. Measure change in size of DCIS on routine imaging (i.e. mammography and/or ultrasound) obtained before and after 4 weeks of treatment with black cohosh, with correlation to specimen sizes; and 2. Determine differences in breast epithelial cell proliferation in areas of DCIS as measured by mean change in levels of Ki67 before and after 4 weeks of treatment with black cohosh. Ki67 levels will be assessed with traditional immunohistochemical staining as well as AQUA technology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess adherence to a brief course of black cohosh. | 4 weeks | To test this secondary hypothesis, we will: Assess adherence to a brief course of black cohosh. Participants will be given an adequate supply of medication for 4 weeks +/- 1 week at the screening/enrollment visit. They will be instructed to bring their medication back on the day of surgery. Pill counts will be conducted by the research nurse to assess the participant's level of compliance. |
| Assess safety and side effects of 4 week course of black cohosh | 4 weeks | To assess this secondary outcome measure we will: Assess safety and side effects through patient history, pill diary and safety labs. |
Countries
United States
Outcome results
None listed