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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Breast Cancer
Interventions Drug: Broccoli sprout extract
Drug: Mango juice
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Broccoli Sprout Extract and Mango Juice Mango Juice
Hide Arm/Group Description

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).

Broccoli sprout extract (sulforaphane): Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to receive a prepartion of broccoli sprout extract and mango juice. 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.

Patients will be randomized to 14 day intervention of mango juice without broccoli sprout extract. All women will be on a cruciferous free diet for the duration of the study (14 days).Mango juice without extract: Mango juice without broccoli sprout extract.

B Mango juice: Women newly diagnosed with DCIS on core biopsy prior to definitive surgery will be randomized to receive 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.

Period Title: Overall Study
Started 17 17
Completed 15 15
Not Completed 2 2
Reason Not Completed
Surgery date change             1             0
Preop values out of acceptable range             1             1
Pregnancy             0             1
Arm/Group Title Broccoli Sprout Extract and Mango Juice Mango Juice Total
Hide Arm/Group Description

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).

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.

Patients will be randomized to 14 day intervention of Mango juice without broccoli extract. All women will be on a cruciferous free diet for the duration of the study (14 days).

Mango juice: 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.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  86.7%
12
  80.0%
25
  83.3%
>=65 years
2
  13.3%
3
  20.0%
5
  16.7%
[1]
Measure Description: Age collected on baseline survey. Participants had to be 18+ years old
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
52
(35 to 71)
54
(40 to 72)
53
(35 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
15
 100.0%
15
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15
 100.0%
15
 100.0%
30
 100.0%
1.Primary Outcome
Title Absolute Change in Mean Proliferative Rate Measured by Ki67%
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the 14-day intervention on either study arm were included in analysis.
Arm/Group Title Broccoli Sprout Extract and Mango Juice Mango Juice Without Extract
Hide Arm/Group Description:
Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days).
Patients will be randomized to 14 day intervention of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of Ki67
-1.15  (2.08) 4  (17.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Broccoli Sprout Extract and Mango Juice, Mango Juice Without Extract
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Broccoli Sprout Extract and Mango Juice Mango Juice Without Extract
Hide Arm/Group Description:
Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days).
Patients will be randomized to 14 day intervention of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: % change of expression in tumor cells
AKR1C1 62.1  (312.99) 867.4  (2097.8)
NQO1 730.98  (2411.96) 6.34  (30.12)
Time Frame 14 days during the intervention period (prior to first and 3 times during intervention)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Broccoli Sprout Extract and Mango Juice Mango Juice
Hide Arm/Group Description

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).

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.

Patients will be randomized to 14 day intervention of Mango juice without broccoli extract. All women will be on a cruciferous free diet for the duration of the study (14 days).

Mango juice: 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.

All-Cause Mortality
Broccoli Sprout Extract and Mango Juice Mango Juice
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
Broccoli Sprout Extract and Mango Juice Mango Juice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Broccoli Sprout Extract and Mango Juice Mango Juice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/15 (60.00%)      9/15 (60.00%)    
Gastrointestinal disorders     
constipation  1  5/15 (33.33%)  9 4/15 (26.67%)  7
intestional gas/bloating  1  4/15 (26.67%)  6 2/15 (13.33%)  6
upset stomach/indigestion  1  1/15 (6.67%)  1 1/15 (6.67%)  1
nausea/vomiting  1  1/15 (6.67%)  2 0/15 (0.00%)  0
abdominal cramps  1  0/15 (0.00%)  0 2/15 (13.33%)  2
diarrhea  1  1/15 (6.67%)  1 0/15 (0.00%)  0
appetite/ taste alteration  1  2/15 (13.33%)  2 1/15 (6.67%)  1
Nervous system disorders     
light headed/ mild anxiety  1  1/15 (6.67%)  1 1/15 (6.67%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Eligible patients had to have their definitive breast cancer surgery at Johns Hopkins Hospital
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kala Visvanathan
Organization: Sidney Kimmel Comprehensive Cancer Center
Phone: 410-614-1112
EMail: kvisvan1@jhu.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00982319    
Other Study ID Numbers: J0822
First Submitted: September 22, 2009
First Posted: September 23, 2009
Results First Submitted: July 5, 2018
Results First Posted: July 31, 2018
Last Update Posted: November 21, 2018