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Sulforaphane: A Dietary HDAC Inhibitor in DCIS


Phase 2
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Precancerous Condition

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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 UniversityPortland, Oregon  97239-3098