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

This study has been completed.
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00982319
First received: September 22, 2009
Last updated: October 5, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Broccoli sprout extract (sulforaphane) Dietary Supplement: Mango juice without extract Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • A decrease in the mean proliferative rate measured by Ki67% [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • An increase in mRNA transcript levels of specific cytoprotective enzymes known to be modulated by sulforaphane and related protein expression as well as qualitative assessment of morphological changes in DCIS specimens and adjacent normal tissue [ Time Frame: 14 days ]

Enrollment: 34
Study Start Date: April 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Broccoli sprout extract and mango juice
Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice compared to a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).
Drug: Broccoli sprout extract (sulforaphane)
Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to either a prepartion of broccoli sprout extract and mango juice or a placebo preparation of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days) and complete a daily dietary check list. Twelve hour urine collections and blood samples will be collected at various time points during the study. Acceptability of the 14 day dose will be evaluated by monitoring indices of compliance, including urinary measurements of ITC excretion, the daily food check list and a questionnaire administered at the end of the study.
Other Name: Sulforaphane
Placebo Comparator: Mango juice Dietary Supplement: Mango juice without extract
Mango juice without broccoli sprout extract
Other Name: Mango Juice

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982319

Locations
United States, Maryland
Johns Hopkins Medical Institution
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Breast Cancer Research Foundation
Investigators
Principal Investigator: Kala Visvanathan, MD Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00982319     History of Changes
Other Study ID Numbers: J0822
Study First Received: September 22, 2009
Last Updated: October 5, 2016

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Broccoli Sprout Extract
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 21, 2017