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Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

A decrease in the mean proliferative rate measured by Ki67%

Outcome Time Frame:

14 days

Safety Issue:

No

Principal Investigator

Kala Visvanathan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

J0822

NCT ID:

NCT00982319

Start Date:

April 2009

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Broccoli Sprout Extract
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Johns Hopkins Medical InstitutionBaltimore, Maryland  21205