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A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
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.
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.
Age
21 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Roswell Park Cancer Institute
Buffalo, New York, United States
Start Date
May 21, 2013
Primary Completion Date
July 23, 2018
Completion Date
August 23, 2018
Last Updated
October 31, 2019
30
ACTUAL participants
Broccoli Sprout Extract
DRUG
Laboratory Biomarker Analysis
OTHER
Pharmacological Study
OTHER
Placebo
OTHER
Lead Sponsor
Roswell Park Cancer Institute
Collaborators
NCT04084730
NCT03213041
Data Source & Attribution
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