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: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Breast Cancer
Precancerous Condition
Dietary Supplement: broccoli sprout extract
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sulforaphane: A Dietary Histone Deacetylase (HDAC) Inhibitor in Ductal Carcinoma in Situ (DCIS)

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Change in isothiocyanate in urine and blood samples as assessed at baseline and after completion of study therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Change in Ki-67 and apoptosis as assessed at baseline and after completion of study therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Change in H3 and H4 as assessed by IHC at baseline and after completion of study therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Change in HDAC activity as assessed at baseline and after completion of study therapy [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and toxicity as assessed by National Cancer Institute's (NCI) Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 [ Time Frame: Regular intervals ] [ Designated as safety issue: Yes ]
  • Treatment compliance [ Time Frame: Regular intervals ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: August 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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: Arm II
Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.
Other: placebo
Given orally

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.

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843167

Locations
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
Investigators
Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00843167     History of Changes
Other Study ID Numbers: CDR0000634111, R21CA132236, P30CA069533, OHSU-4702
Study First Received: February 12, 2009
Last Updated: May 6, 2014
Health Authority: United States: Federal Government

Keywords provided by OHSU Knight Cancer Institute:
mammography
biopsy
ductal breast carcinoma in situ
atypical ductal breast hyperplasia

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Precancerous Conditions
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014