Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

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 key component of broccoli sprouts increases the levels of protective enzymes in breast tissue. In addition, the investigators will also examine how acceptable the broccoli sprouts preparation is to the study participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Breast Cancer Research Foundation
• Treatments: Sulforafan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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