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Broccoli Sprout Extract in Treating Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT01753908
Recruitment Status : Recruiting
First Posted : December 20, 2012
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This randomized pilot trial studies broccoli sprout extract in treating patients with breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract may help determine if it can enter breast tumor cells and how it affects certain biomarkers.

Condition or disease Intervention/treatment
Ductal Breast Carcinoma Ductal Breast Carcinoma In Situ Estrogen Receptor Negative Estrogen Receptor Positive Invasive Breast Carcinoma Lobular Breast Carcinoma Postmenopausal Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Drug: Broccoli Sprout Extract Other: Laboratory Biomarker Analysis Other: Pharmacological Study Other: Placebo

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells.

II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3).

III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta.

IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression.

SECONDARY OBJECTIVES:

I. To determine tolerability of ITC-BSE and compliance in breast cancer patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery.

ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery.

After completion of study treatment, patients are followed up at 30 days.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
Actual Study Start Date : May 21, 2013
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm I (broccoli sprout extract)
Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.
Drug: Broccoli Sprout Extract
Given PO
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Urinary ITCs and metabolites measured
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Urinary ITCs and metabolites measured
Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy


Outcome Measures

Primary Outcome Measures :
  1. Changes in apoptosis (cleaved caspase 3) [ Time Frame: Baseline to up to 14 days ]
    Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.

  2. Changes in cell proliferation (Ki-67) [ Time Frame: Baseline to up to 14 days ]
    Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.

  3. Changes in estrogen receptor expression (ER alpha and ER beta) [ Time Frame: Baseline to up to 14 days ]
    Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.

  4. Changes in NQO1 expression [ Time Frame: Baseline to up to 14 days ]
    Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal (no menstrual cycle in the past 12 months)
  • Diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage I or II, ER positive or negative breast cancer, or ductal carcinoma in situ (DCIS)
  • No neoadjuvant endocrine therapy or chemotherapy within 12 months
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Willing to avoid cruciferous vegetable intake during the study period (2 weeks)
  • Demonstrate the ability to swallow and retain oral medication
  • Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Prior invasive breast cancer, prior mastectomy or breast radiation within 12 months
  • Current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor or other estrogen inhibitors within the last 90 days, which may affect biomarkers
  • Intolerance to broccoli/ITC-BSE taste
  • Current ingestion of broccoli sprout extract, which may confound study results
  • Current or recent treatment for any malignancy within the last one year, which may affect biomarkers
  • History of Crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract
  • Current diagnosis of Gastroesophageal Reflux Disease (GERD) with grade >3
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753908


Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Jessica S. Young         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jessica Young Roswell Park Cancer Institute
More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01753908     History of Changes
Other Study ID Numbers: I 211911
NCI-2012-01770 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 211911 ( Other Identifier: Roswell Park Cancer Institute )
K07CA148888 ( U.S. NIH Grant/Contract )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary