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

NCT01628536 | Completed DMC

• 1 other identifier: 1205010204
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductal Carcinoma in Situ

Keywords

Black Cohosh; Ductal Carcinoma in situ; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Measure change in size of DCIS on routine imaging

  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.

  4 weeks

Secondary Outcomes (2)

• Assess adherence to a brief course of black cohosh.

  4 weeks

• Assess safety and side effects of 4 week course of black cohosh

  4 weeks

Study Arms (1)

Black cohosh

EXPERIMENTAL

Dietary Supplement: Black cohosh

Interventions

Black cohosh DIETARY_SUPPLEMENT

Remifemin 20 mg tablet orally twice per day x 4 weeks

Also known as: Remifemin

Black cohosh

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Erin Hofstatter, MD

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Trant AA, Chagpar A, Wei W, Neumeister V, Rimm D, Stavris K, Lurie B, Frederick C, Andrejeva L, Raghu M, Killelea B, Horowitz N, Lannin D, Knill-Selby E, Sturrock T, Hofstatter E. The Effect of Black Cohosh on Ki67 expression and Tumor Volume: A Pilot Study of Ductal Carcinoma in Situ Patients. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221137290. doi: 10.1177/15347354221137290.

  PMID: 36444764 DERIVED

Related Links

• Yale Cancer Center Studies

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

black cohosh root extract; Remifemin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Erin Hofstatter, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 26, 2012
• Study Start: June 1, 2012
• Primary Completion: January 14, 2016
• Study Completion: June 1, 2016
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

US (1)