Clinical trial NCT00982319: Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
Official title: Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Broccoli Sprout Extract
Breast Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2009-09-23
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 below). The primary study endpoint will be a decrease in the mean proliferative rate measured by Ki67%.

Women diagnosed with DCIS on core or incisional/excisional biopsy scheduled for definitive surgery at Johns Hopkins Hospital will be recruited for this study. Participants will be placed on a cruciferous free diet for the 14 days prior to their surgical date and drink a randomized intervention beverage (mango juice with or without broccoli sprout extract). Additionally participants will provide 2 blood and 2 urine sample collections, report medication use and adverse events using prepared forms and complete a daily diet check list during the 14 day intervention. On the day of definitive breast surgery, 1-2 grams of breast tissue (including normal adjacent breast tissue) will be collected during surgery.

Eligibility 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

Primary outcomes:
measure: Absolute Change in Mean Proliferative Rate Measured by Ki67%
timeFrame: Change from baseline to 14 days post-intervention
Secondary outcomes:
measure: Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor
timeFrame: Change from baseline to 14 days post-intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institution
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center
name: Kala Visvanathan, MD
role: PRINCIPAL_INVESTIGATOR
References: