Back to resultsA Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
Primary Purpose
Ductal Carcinoma in Situ
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Black cohosh
Sponsored by
About this trial
This is an interventional treatment trial for Ductal Carcinoma in Situ focused on measuring Black Cohosh, Ductal Carcinoma in situ, Breast Cancer
Eligibility Criteria
Inclusion Criteria:
A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:
- Pre- and post-menopausal women ≥ 18 years of age newly diagnosed with DCIS histologically confirmed on breast core biopsy
- Ability to understand and the willingness to sign a written informed consent document
- ECOG performance status 0-1
- Life expectancy >12 months
- Willing to schedule definitive resection of DCIS 4 weeks +/- 1 week after study enrollment
- 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:
- Pregnant or nursing within past 6 months
- Lactose intolerant, lactose allergy or salicylate allergy
- Patients who have already undergone excisional biopsy for qualifying DCIS
- Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study
- Patients receiving any other chemotherapy or investigational agents
- 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.
- Liver function tests ≥ 20% of the institutional upper limits of normal
- Creatinine > 1.5 times the institutional upper limit of normal
- ANC < 1,500 /µL
- Platelets < 100,000 /µL
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to black cohosh
- 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.
Prior/concurrent therapy including:
Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months
- Chemotherapy, biologic therapy (e.g., trastuzumab [Herceptin®]), or breast radiotherapy to the breast currently affected by DCIS within the past 12 months
- Any exogenous hormonal therapy including estrogen-, progesterone-, and/or androgen-based agents in the past 6 months
- Phytoestrogens or OTC medications with estrogenic or androgenic properties in the past 6 months
- Any black cohosh preparation within the past 6 months
Sites / Locations
- Erin Hofstatter, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Black cohosh
Arm Description
Outcomes
Primary Outcome Measures
Measure change in size of DCIS on routine imaging
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.
Secondary Outcome Measures
Assess adherence to a brief course of black cohosh.
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
To assess this secondary outcome measure we will:
Assess safety and side effects through patient history, pill diary and safety labs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01628536
Brief Title
A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
Official Title
A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 14, 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma in Situ
Keywords
Black Cohosh, Ductal Carcinoma in situ, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Black cohosh
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Black cohosh
Other Intervention Name(s)
Remifemin
Intervention Description
Remifemin 20 mg tablet orally twice per day x 4 weeks
Primary Outcome Measure Information:
Title
Measure change in size of DCIS on routine imaging
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Assess adherence to a brief course of black cohosh.
Description
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.
Time Frame
4 weeks
Title
Assess safety and side effects of 4 week course of black cohosh
Description
To assess this secondary outcome measure we will:
Assess safety and side effects through patient history, pill diary and safety labs.
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:
Pre- and post-menopausal women ≥ 18 years of age newly diagnosed with DCIS histologically confirmed on breast core biopsy
Ability to understand and the willingness to sign a written informed consent document
ECOG performance status 0-1
Life expectancy >12 months
Willing to schedule definitive resection of DCIS 4 weeks +/- 1 week after study enrollment
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:
Pregnant or nursing within past 6 months
Lactose intolerant, lactose allergy or salicylate allergy
Patients who have already undergone excisional biopsy for qualifying DCIS
Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study
Patients receiving any other chemotherapy or investigational agents
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.
Liver function tests ≥ 20% of the institutional upper limits of normal
Creatinine > 1.5 times the institutional upper limit of normal
ANC < 1,500 /µL
Platelets < 100,000 /µL
History of allergic reactions attributed to compounds of similar chemical or biologic composition to black cohosh
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.
Prior/concurrent therapy including:
Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months
Chemotherapy, biologic therapy (e.g., trastuzumab [Herceptin®]), or breast radiotherapy to the breast currently affected by DCIS within the past 12 months
Any exogenous hormonal therapy including estrogen-, progesterone-, and/or androgen-based agents in the past 6 months
Phytoestrogens or OTC medications with estrogenic or androgenic properties in the past 6 months
Any black cohosh preparation within the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Hofstatter, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erin Hofstatter, MD
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.yalestudies.org
Description
Yale Cancer Center Studies
Learn more about this trial
A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
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