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Broccoli Sprout Extract in Treating Patients With Breast Cancer

Primary Purpose

Ductal Breast Carcinoma, Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Broccoli Sprout Extract
Laboratory Biomarker Analysis
Pharmacological Study
Placebo
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ductal Breast Carcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (broccoli sprout extract)

Arm II (placebo)

Arm Description

Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2012
Last Updated
October 29, 2019
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01753908
Brief Title
Broccoli Sprout Extract in Treating Patients With Breast Cancer
Official Title
A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 21, 2013 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (broccoli sprout extract)
Arm Type
Experimental
Arm Description
Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Broccoli Sprout Extract
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Urinary ITCs and metabolites measured
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Changes in apoptosis (cleaved caspase 3)
Description
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.
Time Frame
Baseline to up to 14 days
Title
Changes in cell proliferation (Ki-67)
Description
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.
Time Frame
Baseline to up to 14 days
Title
Changes in estrogen receptor expression (ER alpha and ER beta)
Description
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.
Time Frame
Baseline to up to 14 days
Title
Changes in NQO1 expression
Description
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.
Time Frame
Baseline to up to 14 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Young
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

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Broccoli Sprout Extract in Treating Patients With Breast Cancer

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