Ductal Carcinoma in SituNCT01628536
A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
A study testing Black cohosh in people with Ductal Carcinoma in Situ, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- Black cohosh
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Black cohosh
- Keywords
- Black Cohosh, Ductal Carcinoma in situ, Breast Cancer
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black cohoshDietary supplement
Also called Remifemin
Remifemin 20 mg tablet orally twice per day x 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Black cohosh | Experimental | Not described Receives: Dietary Supplement: Black cohosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJun 2012
- Primary completion14 Jan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Hofstatter, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628536
- Sponsor's protocol ID
- 1205010204
- Status last verified
- Oct 2023
- First submitted
- 20 Jun 2012
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36444764
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
- ClinicalTrials.gov ID
- NCT01628536
- Acronym / sponsor ID
- 1205010204
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- Black Cohosh, Ductal Carcinoma in situ, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 14 Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Black cohosh | Experimental | Dietary Supplement: Black cohosh |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:
Key exclusion criteria (19 listed)
- A patient /subject will not be eligible for this study if any of the following exclusion criteria are met:
- Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black cohoshAlso: RemifeminRemifemin 20 mg tablet orally twice per day x 4 weeks | Dietary supplement | Black cohosh |
Primary outcome
Measure change in size of DCIS on routine imaging
Time frame: 4 weeks
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.
2 secondary outcomes
Assess adherence to a brief course of black cohosh.
Time frame: 4 weeks
Assess safety and side effects of 4 week course of black cohosh
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Derived from this study: PubMed 36444764Trant 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.
- Yale Cancer Center StudiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Hofstatter, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black cohosh in people with Ductal Carcinoma in Situ, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure change in size of DCIS on routine imaging (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01628536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.