Sulforaphane: A Dietary HDAC Inhibitor in DCIS
21 Years
N/A
Female
Breast Cancer, Precancerous Condition
Trial Information
Sulforaphane: A Dietary HDAC Inhibitor in DCIS
OBJECTIVES:
- 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
hyperplasia.
- To determine the effect of this supplement on biomarkers of prognosis in these
patients.
- 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.
Inclusion Criteria
INCLUSION CRITERIA:
- Diagnostic mammogram
- English speaking
EXCLUSION CRITERIA:
- Pregnancy (as determined by urine hCG test)
- No biopsy referral after diagnostic mammogram
- Patient reported breast feeding
- Significant active medical illness which in the opinion of the investigator would
preclude protocol treatment
- History of or active liver disease or baseline total bilirubin greater than
institutional upper limit of normal
- Patient reported allergy or sensitivity to cruciferous vegetables
- Use of oral antibiotics within three months prior to randomization
- Oral steroid therapy at enrollment
- Current therapy with valproate acid or SAHA
- Current use of nutrient supplements or herbal remedies containing sulforaphane and
unwillingness or inability to quit 72 hours prior to randomization and for the
duration of the trial
- Radiation for currently-diagnosed disease prior to or during study supplementation
- Chemotherapy for currently-diagnosed disease prior to or during study supplementation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Change in isothiocyanate in urine and blood samples as assessed at baseline and after completion of study therapy
Outcome Time Frame:
End of study
Safety Issue:
No
Principal Investigator
Jackilen Shannon, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000634111
NCT ID:
NCT00843167
Start Date:
August 2009
Completion Date:
Related Keywords:
- Breast Cancer
- Precancerous Condition
- mammography
- biopsy
- ductal breast carcinoma in situ
- atypical ductal breast hyperplasia
- Breast Neoplasms
- Precancerous Conditions
Name | Location |
|---|---|
| Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
