Broccoli Sprout Extract in Treating Patients With Breast Cancer

Invasive Breast Carcinoma Clinical Trial

Official title:

A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753908
• Other study ID #: I 211911
• Secondary ID: NCI-2012-01770I
• Status: Completed
• Phase: Early Phase 1
• Start date: May 21, 2013
• Est. completion date: August 23, 2018

Study information

• Verified date: October 2019
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 23, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• 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

Intervention

Drug:
• Broccoli Sprout Extract
Given PO

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Pharmacological Study
Urinary ITCs and metabolites measured
• Placebo
Given PO

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in apoptosis (cleaved caspase 3)	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.	Baseline to up to 14 days
Primary	Changes in cell proliferation (Ki-67)	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.	Baseline to up to 14 days
Primary	Changes in estrogen receptor expression (ER alpha and ER beta)	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.	Baseline to up to 14 days
Primary	Changes in NQO1 expression	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.	Baseline to up to 14 days