Status:
COMPLETED
Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research is to examine the effect of a broccoli sprout preparation on specific factors in breast tissue that are related to breast cancer risk and to assess whether sulforaphane a ...
Detailed Description
A double-blind randomized Phase II chemoprevention trial of BSE versus placebo will be conducted in up to 35 women diagnosed with DCIS on core biopsy prior to their definitive surgery (study diagram b...
Eligibility Criteria
Inclusion
- Female 18 + years of age
- Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery
- Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening
- Agree to avoid cruciferous vegetable/condiment intake for 14 days
- Agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes
Exclusion
- Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ
- Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening
- Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)
- Smoked within the past 12 months prior to eligibility screening;
- Active infection or inflammation of the breast at time of eligibility screening
- Has baseline comprehensive metabolic panel (CMP) \[Glucose, Calcium, Albumin, Serum total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST), Aspartate amino transferase (SGOT), and Bilirubin\], prothrombin time (PT) and , complete blood count (CBC) values that are 1.5 times in either direction the reported normal range
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00982319
Start Date
April 1 2009
End Date
November 1 2013
Last Update
November 21 2018
Active Locations (1)
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1
Johns Hopkins Medical Institution
Baltimore, Maryland, United States, 21205