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

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ClinicalTrials.gov Identifier: NCT00982319
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : July 31, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE September 23, 2009
Results First Submitted Date  ICMJE July 5, 2018
Results First Posted Date  ICMJE July 31, 2018
Last Update Posted Date November 21, 2018
Study Start Date  ICMJE April 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
Absolute Change in Mean Proliferative Rate Measured by Ki67% [ Time Frame: Change from baseline to 14 days post-intervention ]
Pathologists score the slides without knowledge of treatment assignment at the end of the study. All pre-post samples from one individual will be evaluated together. Quality control for these stains is performed routinely in the immunohistochemistry lab (using lymphoid tissue for Ki67). Initial scoring is performed where possible on a minimum of 3000 cells, by counting the number of positive cells divided by the total number of cells. DCIS lesions will be scored separately to adjacent normal tissue. The rationale for selecting Ki67 as a measure of cellular proliferation includes the robustness of the staining reaction, correlation with the S phase fraction of the cell cycle and mitotic index and that it can be successfully ascertained from core breast biopsies provided there is an adequate yield of epithelial cells. A negative value reflects a decrease in ki67 positive cells, therefore a decrease in cellular proliferation.
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
A decrease in the mean proliferative rate measured by Ki67% [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor [ Time Frame: Change from baseline to 14 days post-intervention ]
Phase II protein expression of cytoprotective enzymes known to be modulated by sulforaphane in DCIS specimens. Cytoprotective enzymes measured (NQ01 and AKR1C1 expression) based on immunohistochemical analysis. Expression was categorized by the study pathologist based on percentage of cells expressing antibody on the slide.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
Official Title  ICMJE Evaluating the Effect of Broccoli Sprouts (Sulforaphane) on Cellular Proliferation, an Intermediate Marker of Breast Cancer Risk
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Broccoli sprout extract
    100 µmols of sulforaphane (dissolvable)
  • Drug: Mango juice
    150 mL of mango juice
Study Arms  ICMJE
  • Experimental: Broccoli sprout extract
    Patients will be randomized to 14 day intervention of broccoli sprout extract and mango juice consisting of a dose of 100 µmols of sulforaphane dissolved in 150 mL mango juice once a day.
    Interventions:
    • Drug: Broccoli sprout extract
    • Drug: Mango juice
  • Placebo Comparator: Mango juice
    Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.
    Intervention: Drug: Mango juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2014)
34
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2009)
28
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00982319
Other Study ID Numbers  ICMJE J0822
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Breast Cancer Research Foundation
Investigators  ICMJE
Principal Investigator: Kala Visvanathan, MD Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP