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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Erin Hofstatter, Yale University
ClinicalTrials.gov Identifier:
NCT01628536
First received: June 20, 2012
Last updated: June 27, 2012
Last verified: June 2012

June 20, 2012
June 27, 2012
June 2012
June 2013   (final data collection date for primary outcome measure)
Measure change in size of DCIS on routine imaging [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  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.
Same as current
Complete list of historical versions of study NCT01628536 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ductal Carcinoma in Situ
Dietary Supplement: Black cohosh
Remifemin 20 mg tablet orally twice per day x 4 weeks
Other Name: Remifemin
Experimental: Black cohosh
Intervention: Dietary Supplement: Black cohosh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 90 Years
No
United States
 
NCT01628536
EH0524BlackCohosh
Yes
Erin Hofstatter, Yale University
Yale University
Not Provided
Principal Investigator: Erin Hofstatter, MD Yale University
Yale University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP