Clinical Trial: A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ

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 Summary: 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.
Sponsor: Yale University

Current Primary Outcome: Measure change in size of DCIS on routine imaging [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assess adherence to a brief course of black cohosh. [ Time Frame: 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 [ Time Frame: 4 weeks ]

    To assess this secondary outcome measure we will:

    Assess safety and side effects through patient history, pill diary and safety labs.



Original Secondary Outcome: Same as current

Information By: Yale University

Dates:
Date Received: June 20, 2012
Date Started: June 2012
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2016