A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
This study is currently recruiting participants.
Verified June 2012 by Yale University
Sponsor:
Yale University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Ductal Carcinoma in Situ |
Dietary Supplement: Black cohosh |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
Further study details as provided by Yale University:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 22 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Black cohosh |
Dietary Supplement: Black cohosh
Remifemin 20 mg tablet orally twice per day x 4 weeks
Other Name: Remifemin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628536
Locations
| United States, Connecticut | |
| Erin Hofstatter, MD | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Erin Hofstatter, MD 203-737-1600 erin.hofstatter@yale.edu | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Erin Hofstatter, MD | Yale University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Erin Hofstatter, Assistant Professor - Yale Cancer Center, Yale University |
| ClinicalTrials.gov Identifier: | NCT01628536 History of Changes |
| Other Study ID Numbers: | EH0524BlackCohosh |
| Study First Received: | June 20, 2012 |
| Last Updated: | June 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Yale University:
|
Black Cohosh Ductal Carcinoma in situ Breast Cancer |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Breast Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013