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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Precancerous Condition Dietary Supplement: broccoli sprout extract Other: placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sulforaphane: A Dietary Histone Deacetylase (HDAC) Inhibitor in Ductal Carcinoma in Situ (DCIS)
Study Start Date : August 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843167


Locations
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United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jackie Shannon, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00843167    
Other Study ID Numbers: CDR0000634111
R21CA132236 ( U.S. NIH Grant/Contract )
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-4702 ( Other Identifier: OHSU IRB )
First Posted: February 13, 2009    Key Record Dates
Results First Posted: February 24, 2015
Last Update Posted: April 27, 2017
Last Verified: October 2015
Keywords provided by Jackie Shannon, OHSU Knight Cancer Institute:
mammography
biopsy
ductal breast carcinoma in situ
atypical ductal breast hyperplasia
Additional relevant MeSH terms:
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Carcinoma in Situ
Precancerous Conditions
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms