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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00843167
First received: February 12, 2009
Last updated: February 20, 2015
Last verified: February 2015

February 12, 2009
February 20, 2015
August 2009
December 2013   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.
  • Change in isothiocyanate in urine, blood, and nipple aspirate fluid samples as assessed at baseline and after completion of study therapy [ Designated as safety issue: No ]
  • Change in Ki-67 and apoptosis as assessed at baseline and after completion of study therapy [ Designated as safety issue: No ]
  • Change in HDAC activity as assessed at baseline and after completion of study therapy [ Designated as safety issue: No ]
  • Change in H3 and H4 as assessed by IHC at baseline and after completion of study therapy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00843167 on ClinicalTrials.gov Archive Site
Treatment Compliance [ Time Frame: Baseline and end of study (up to 8 weeks) ] [ Designated as safety issue: No ]
  • Safety and toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Treatment compliance [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Breast Cancer
  • Precancerous Condition
  • Dietary Supplement: broccoli sprout extract
    Given orally
  • Other: placebo
    Given orally
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00843167
CDR0000634111, R21CA132236, P30CA069533, OHSU-4702
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
February 2015

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