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

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ClinicalTrials.gov Identifier: NCT00843167
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : February 24, 2015
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jackie Shannon, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 12, 2009
First Posted Date  ICMJE February 13, 2009
Results First Submitted Date  ICMJE December 30, 2014
Results First Posted Date  ICMJE February 24, 2015
Last Update Posted Date April 27, 2017
Study Start Date  ICMJE August 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
  • Change in isothiocyanate in urine, blood, and nipple aspirate fluid samples as assessed at baseline and after completion of study therapy
  • Change in Ki-67 and apoptosis as assessed at baseline and after completion of study therapy
  • Change in H3 and H4 as assessed by IHC at baseline and after completion of study therapy
  • Change in HDAC activity as assessed at baseline and after completion of study therapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
  • Safety and toxicity as assessed by NCI CTCAE v3.0
  • Treatment Compliance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Official Title  ICMJE Sulforaphane: A Dietary Histone Deacetylase (HDAC) Inhibitor in Ductal Carcinoma in Situ (DCIS)
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Precancerous Condition
Intervention  ICMJE
  • Dietary Supplement: broccoli sprout extract
    Given orally
  • Other: placebo
    Given orally
Study Arms  ICMJE
  • Experimental: Sulforaphane Supplement
    Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
    Intervention: Dietary Supplement: broccoli sprout extract
  • Placebo Comparator: Placebo
    Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
54
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2009)
66
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00843167
Other Study ID Numbers  ICMJE CDR0000634111
R21CA132236 ( U.S. NIH Grant/Contract )
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-4702 ( Other Identifier: OHSU IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jackie Shannon, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP