Broccoli Sprout Extract trials/dcis

Hindsfeet

http://clinicaltrials.gov/ct2/show/NCT00843167

Description:

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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843167

Contacts

Contact: Jackilen Shannon, PhD		mailto:shannoja%40ohsu.edu?subject=NCT00843167, CDR0000634111, Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Contact: Paige E Farris, MSW		mailto:farrisp%40ohsu.edu?subject=NCT00843167, CDR0000634111, Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy

Locations

United States, Oregon
Knight Cancer Institute at Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Phyllis Carello     503-494-0164     mailto:carellop%40ohsu.edu?subject=NCT00843167, CDR0000634111, Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Contact: Paige E Farris, MSW     503-220-8262 ext 54868     mailto:farrisp%40ohsu.edu?subject=NCT00843167, CDR0000634111, Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy