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

April 25, 2017 updated by: Jackie Shannon, OHSU Knight Cancer Institute

Sulforaphane: A Dietary Histone Deacetylase (HDAC) Inhibitor in Ductal Carcinoma in Situ (DCIS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Knight Cancer Institute At Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sulforaphane Supplement
Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
Dietary supplement: broccoli sprout extract
Given orally
PLACEBO_COMPARATOR: Placebo
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
Other: placebo
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy
Time Frame: Baseline and end of study (up to 8 weeks)
Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.
Baseline and end of study (up to 8 weeks)
Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy
Time Frame: Baseline and end of study (up to 8 weeks)
Ki-67 was measured through immunohistochemistry method. A modified H-score was recorded, which involved semi-quantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate staining, and 3 strong staining) and percentage of positive cells. The range of the H-score was 0-300. The maximum score indicates the strongest expression, the minimum score indicates no expression of positive tumor area.
Baseline and end of study (up to 8 weeks)
Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy
Time Frame: Baseline and End of Study (up to 8 weeks)
PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.
Baseline and End of Study (up to 8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Compliance
Time Frame: Baseline and end of study (up to 8 weeks)
For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant.
Baseline and end of study (up to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (ESTIMATE)

February 13, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000634111
  • P30CA069533 (U.S. NIH Grant/Contract)
  • R21CA132236 (NIH)
  • OHSU-4702 (OTHER: OHSU IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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