Status:
COMPLETED
Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Precancerous Condition
Eligibility:
FEMALE
21-120 years
Phase:
PHASE2
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. ...
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 wome...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00843167
Start Date
August 1 2009
End Date
December 1 2013
Last Update
April 27 2017
Active Locations (1)
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1
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098