A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ|
- Measure change in size of DCIS on routine imaging [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- 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
- 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.
- Assess adherence to a brief course of black cohosh. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
To assess this secondary outcome measure we will:
Assess safety and side effects through patient history, pill diary and safety labs.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Experimental: Black cohosh||
Dietary Supplement: Black cohosh
Remifemin 20 mg tablet orally twice per day x 4 weeks
Other Name: Remifemin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628536
|United States, Connecticut|
|Erin Hofstatter, MD||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Erin Hofstatter, MD 203-737-1600 firstname.lastname@example.org|
|Principal Investigator:||Erin Hofstatter, MD||Yale University|