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

NCT ID: NCT01628536

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Ductal Carcinoma in Situ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Black cohosh

Group Type: EXPERIMENTAL

Black cohosh

Intervention Type: DIETARY_SUPPLEMENT

Remifemin 20 mg tablet orally twice per day x 4 weeks

Interventions

Black cohosh

Remifemin 20 mg tablet orally twice per day x 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Remifemin

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Hofstatter, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Erin Hofstatter, MD

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36444764 (View on PubMed)

Other Identifiers

1205010204

Identifier Type: -

Identifier Source: org_study_id