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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01628536
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Erin Hofstatter, Yale University

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.

Condition or disease Intervention/treatment Phase
Ductal Carcinoma in Situ Dietary Supplement: Black cohosh Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
Study Start Date : June 2012
Actual Primary Completion Date : January 14, 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Black cohosh Dietary Supplement: Black cohosh
Remifemin 20 mg tablet orally twice per day x 4 weeks
Other Name: Remifemin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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 exclusion criteria are met:

    1. Pregnant or nursing within past 6 months
    2. Lactose intolerant, lactose allergy or salicylate allergy
    3. Patients who have already undergone excisional biopsy for qualifying DCIS
    4. Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study
    5. Patients receiving any other chemotherapy or investigational agents
    6. Serious concomitant systemic disorders (including active infections) or psychiatric illness/social situations that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
    7. Liver function tests ≥ 20% of the institutional upper limits of normal
    8. Creatinine > 1.5 times the institutional upper limit of normal
    9. ANC < 1,500 /µL
    10. Platelets < 100,000 /µL
    11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to black cohosh
    12. The effects of black cohosh on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
    13. Prior/concurrent therapy including:

      Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months

    14. Chemotherapy, biologic therapy (e.g., trastuzumab [Herceptin®]), or breast radiotherapy to the breast currently affected by DCIS within the past 12 months
    15. Any exogenous hormonal therapy including estrogen-, progesterone-, and/or androgen-based agents in the past 6 months
    16. Phytoestrogens or OTC medications with estrogenic or androgenic properties in the past 6 months
    17. Any black cohosh preparation within the past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01628536

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United States, Connecticut
Erin Hofstatter, MD
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
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Principal Investigator: Erin Hofstatter, MD Yale University

Additional Information:
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Responsible Party: Erin Hofstatter, Assistant Professor - Yale Cancer Center, Yale University Identifier: NCT01628536     History of Changes
Other Study ID Numbers: 1205010204
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2016
Keywords provided by Erin Hofstatter, Yale University:
Black Cohosh
Ductal Carcinoma in situ
Breast Cancer
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ