A Pilot Study of Broccoli Sprout Extract in Patients With Invasive Breast Cancer
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
IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1)
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.
ARM II: Patients receive placebo PO QD on days 1-14.
After completion of study treatment, patients are followed up at 30 days.
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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 14 days
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|