Trial Outcomes & Findings for Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue (NCT NCT00982319)

Last Updated: 2018-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Change from baseline to 14 days post-intervention

Results posted on

2018-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	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). 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.	Mango Juice 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.
Overall Study STARTED	17	17
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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). 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.	Mango Juice 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.
Overall Study Surgery date change	1	0
Overall Study Preop values out of acceptable range	1	1
Overall Study Pregnancy	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Broccoli Sprout Extract and Mango Juice n=15 Participants 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.	Mango Juice n=15 Participants 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 n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	52 years n=5 Participants	54 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 14 days post-intervention

Population: All participants who completed the 14-day intervention on either study arm were included in analysis.

Outcome measures

Outcome measures
Measure	Broccoli Sprout Extract and Mango Juice n=15 Participants 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).	Mango Juice Without Extract n=15 Participants 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).
Absolute Change in Mean Proliferative Rate Measured by Ki67%	-1.15 percentage of Ki67 Standard Deviation 2.08	4 percentage of Ki67 Standard Deviation 17.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Broccoli Sprout Extract and Mango Juice n=15 Participants 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).	Mango Juice Without Extract n=15 Participants 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).
Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor AKR1C1	62.1 % change of expression in tumor cells Standard Deviation 312.99	867.4 % change of expression in tumor cells Standard Deviation 2097.8
Phase II Protein Expression as Assessed by Change in Cytoprotective Enzyme Expression Within Tumor NQO1	730.98 % change of expression in tumor cells Standard Deviation 2411.96	6.34 % change of expression in tumor cells Standard Deviation 30.12

Adverse Events

Broccoli Sprout Extract and Mango Juice

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Mango Juice

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Broccoli Sprout Extract and Mango Juice n=15 participants at risk 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.	Mango Juice n=15 participants at risk 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.
Gastrointestinal disorders constipation	33.3% 5/15 • Number of events 9 • 14 days during the intervention period (prior to first and 3 times during intervention)	26.7% 4/15 • Number of events 7 • 14 days during the intervention period (prior to first and 3 times during intervention)
Gastrointestinal disorders intestional gas/bloating	26.7% 4/15 • Number of events 6 • 14 days during the intervention period (prior to first and 3 times during intervention)	13.3% 2/15 • Number of events 6 • 14 days during the intervention period (prior to first and 3 times during intervention)
Gastrointestinal disorders upset stomach/indigestion	6.7% 1/15 • Number of events 1 • 14 days during the intervention period (prior to first and 3 times during intervention)	6.7% 1/15 • Number of events 1 • 14 days during the intervention period (prior to first and 3 times during intervention)
Gastrointestinal disorders nausea/vomiting	6.7% 1/15 • Number of events 2 • 14 days during the intervention period (prior to first and 3 times during intervention)	0.00% 0/15 • 14 days during the intervention period (prior to first and 3 times during intervention)
Gastrointestinal disorders abdominal cramps	0.00% 0/15 • 14 days during the intervention period (prior to first and 3 times during intervention)	13.3% 2/15 • Number of events 2 • 14 days during the intervention period (prior to first and 3 times during intervention)
Gastrointestinal disorders diarrhea	6.7% 1/15 • Number of events 1 • 14 days during the intervention period (prior to first and 3 times during intervention)	0.00% 0/15 • 14 days during the intervention period (prior to first and 3 times during intervention)
Gastrointestinal disorders appetite/ taste alteration	13.3% 2/15 • Number of events 2 • 14 days during the intervention period (prior to first and 3 times during intervention)	6.7% 1/15 • Number of events 1 • 14 days during the intervention period (prior to first and 3 times during intervention)
Nervous system disorders light headed/ mild anxiety	6.7% 1/15 • Number of events 1 • 14 days during the intervention period (prior to first and 3 times during intervention)	6.7% 1/15 • Number of events 1 • 14 days during the intervention period (prior to first and 3 times during intervention)

Additional Information

Dr. Kala Visvanathan

Sidney Kimmel Comprehensive Cancer Center

Phone: 410-614-1112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place