Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy

OHSU Knight Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Precancerous Condition

Treatments

Dietary Supplement: broccoli sprout extract

Other: placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00843167

CDR0000634111

OHSU-4702 (Other Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

R21CA132236 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal hyperplasia.

PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical ductal hyperplasia.

Full 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.

Sulforaphane Supplement: Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
Placebo: 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.

Enrollment

54 patients

Sex

Female

Ages

21 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnostic mammogram
English speaking

Exclusion criteria

Pregnancy (as determined by urine human chorionic gonadotropin (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