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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Precancerous Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sulforaphane Supplement

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

Group Type EXPERIMENTAL

broccoli sprout extract

Intervention Type DIETARY_SUPPLEMENT

Given orally

Placebo

Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

Interventions

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broccoli sprout extract

Given orally

Intervention Type DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No