Sulforaphane: A Dietary HDAC Inhibitor in DCIS
- To determine the correlation between supplemental sulforaphane (broccoli sprout
extract) dose and concentrations of sulforaphane and its metabolites in blood and urine
samples from women positive for cancer, ductal carcinoma in situ and/or atypical ductal
- To determine the effect of this supplement on biomarkers of prognosis in these
- To determine the effect of this supplement on HDAC inhibition in peripheral blood cell
and normal and cancerous breast tissue samples from these patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral broccoli sprout extract supplementation three times daily
for 2-8 weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo supplementation three times daily for 2-8 weeks
in the absence of unacceptable toxicity.
Blood and urine samples are collected at baseline and after completion of study treatment
for laboratory biomarker studies. Patients scheduled to undergo surgery (mastectomy or
lumpectomy) also undergo breast tissue sample collection at baseline and at the time of
surgery. Samples are analyzed for sulforaphane metabolism (isothiocyanate levels), HDAC
activity (acetylated histone expression), cell proliferation (Ki-67 index by IHC), and
apoptosis (TUNEL assay).
Patients complete questionnaires at baseline and periodically during study about their
dietary history, family history, cruciferous vegetable intake, adverse events, and dietary
and medication changes.
After completion of study therapy, patients are followed at/around 30 days.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Change in isothiocyanate in urine and blood samples as assessed at baseline and after completion of study therapy
End of study
Jackilen Shannon, PhD
OHSU Knight Cancer Institute
United States: Federal Government
|Knight Cancer Institute at Oregon Health and Science University||Portland, Oregon 97239-3098|