Back to resultsStudy to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Broccoli sprout extract
Mango juice
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Broccoli Sprout Extract, Breast Cancer
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
Sites / Locations
- Johns Hopkins Medical Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Broccoli sprout extract
Mango juice
Arm Description
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.
Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.
Outcomes
Primary Outcome Measures
Absolute Change in Mean Proliferative Rate Measured by Ki67%
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.
Secondary Outcome Measures
Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor
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.
Full Information
NCT ID
NCT00982319
First Posted
September 22, 2009
Last Updated
November 16, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Breast Cancer Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00982319
Brief Title
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
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Breast Cancer Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Broccoli Sprout Extract, Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Broccoli sprout extract
Arm Type
Experimental
Arm Description
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.
Arm Title
Mango juice
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.
Intervention Type
Drug
Intervention Name(s)
Broccoli sprout extract
Intervention Description
100 µmols of sulforaphane (dissolvable)
Intervention Type
Drug
Intervention Name(s)
Mango juice
Intervention Description
150 mL of mango juice
Primary Outcome Measure Information:
Title
Absolute Change in Mean Proliferative Rate Measured by Ki67%
Description
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.
Time Frame
Change from baseline to 14 days post-intervention
Secondary Outcome Measure Information:
Title
Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor
Description
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.
Time Frame
Change from baseline to 14 days post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kala Visvanathan, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health and Sidney Kimmel Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Institution
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
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