Trial Outcomes & Findings for Effects of Sulforaphane on Normal Prostate Tissue (NCT NCT00946309)

NCT ID: NCT00946309

Last Updated: 2016-11-15

Results Overview

Change in Phase II enzyme expression

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Baseline and 5 weeks

Results posted on

2016-11-15

Participant Flow

Recruitment occurred from July 2010 to April 2014 at the VA Puget Sound Health Care System.

There were no pre-assignment events. Group assignment occurred at the time of participant enrollment.

Participant milestones

Participant milestones
Measure	Sulforaphane High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks	Placebo Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
Overall Study STARTED	22	23
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Sulforaphane High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks	Placebo Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Procedure cancelled/discontinued	0	3

Baseline Characteristics

Effects of Sulforaphane on Normal Prostate Tissue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sulforaphane n=22 Participants High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks	Placebo n=23 Participants Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	17 Participants n=4 Participants	29 Participants n=27 Participants
Age, Categorical >=65 years	10 Participants n=93 Participants	6 Participants n=4 Participants	16 Participants n=27 Participants
Age, Continuous	62.6 years STANDARD_DEVIATION 5.4 • n=93 Participants	62.8 years STANDARD_DEVIATION 4.3 • n=4 Participants	62.7 years STANDARD_DEVIATION 4.8 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	23 Participants n=4 Participants	45 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) White	16 Participants n=93 Participants	20 Participants n=4 Participants	36 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	22 participants n=93 Participants	23 participants n=4 Participants	45 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 5 weeks

Population: Due to budget restrictions, outcome data from only collected from the first 20 participants

Change in Phase II enzyme expression

Outcome measures

Outcome measures
Measure	Sulforaphane n=10 Participants High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks	Placebo n=10 Participants Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
Gene Expression of Phase II Enzymes RODH5 F2/R2 expression	-0.10 -fold change in expression Standard Deviation 2.6	-0.02 -fold change in expression Standard Deviation 2.6
Gene Expression of Phase II Enzymes Superoxide dismutase (SOD1) expression	0.35 -fold change in expression Standard Deviation 1.1	0.5 -fold change in expression Standard Deviation 1.0
Gene Expression of Phase II Enzymes Glutathione peroxidase 4 (GPX4) expression	-0.36 -fold change in expression Standard Deviation 2.0	0.26 -fold change in expression Standard Deviation 1.1
Gene Expression of Phase II Enzymes Glutathione S-transferase A2 (GSTa2) expression	0.15 -fold change in expression Standard Deviation 4.1	-0.59 -fold change in expression Standard Deviation 3.0
Gene Expression of Phase II Enzymes NAD(P)H:quinone oxidoreductase (NQ01) expression	-0.02 -fold change in expression Standard Deviation 1.3	0.42 -fold change in expression Standard Deviation 0.10

PRIMARY outcome

Timeframe: Baseline and 5 weeks

Population: Outcome data were not collected due to budget restrictions

Blood F2 Isoprostane levels

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Five weeks

Population: Outcome data were not collected due to budget restrictions

Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and 5 weeks

Population: Due to budget restrictions, outcome data from only collected from the first 25 participants

Change in serum dihydrotestosterone (DHT) levels

Outcome measures

Outcome measures
Measure	Sulforaphane n=12 Participants High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks	Placebo n=13 Participants Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
DHT Levels	2.09 pg/mL Standard Deviation 77.8	19.33 pg/mL Standard Deviation 98.0

PRIMARY outcome

Timeframe: Baseline and 5 weeks

Population: Due to budget restrictions, outcome data from only collected from the first 25 participants

Change in testosterone (T) levels

Outcome measures

Outcome measures
Measure	Sulforaphane n=12 Participants High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks	Placebo n=13 Participants Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
Testosterone Levels	-36.79 ng/dL Standard Deviation 79.1	5.75 ng/dL Standard Deviation 156.8

PRIMARY outcome

Timeframe: Baseline and 5 weeks

Population: Due to budget restrictions, outcome data from only collected from the first 25 participants

Change in serum 3-alpha-diol gluconate(3α-DG) levels

Outcome measures

Outcome measures
Measure	Sulforaphane n=12 Participants High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks	Placebo n=13 Participants Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
3-alpha-diol Gluconate Levels	-0.69 ng/mL Standard Deviation 1.6	0.39 ng/mL Standard Deviation 1.2

Adverse Events

Sulforaphane

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Daniel Lin

Fred Hutchinson Cancer Research Center

Phone: 206-221-0797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sulforaphane n=21 participants at risk High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks	Placebo n=23 participants at risk Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
Gastrointestinal disorders Burping (Grade 1)	19.0% 4/21 • Number of events 8 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	26.1% 6/23 • Number of events 6 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Burping (Grade 2)	4.8% 1/21 • Number of events 3 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	0.00% 0/23 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Abdominal Bloating (Grade 1)	23.8% 5/21 • Number of events 6 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	13.0% 3/23 • Number of events 3 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Abdominal bloating (Grade 2)	4.8% 1/21 • Number of events 3 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	0.00% 0/23 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Heartburn (Grade 1)	23.8% 5/21 • Number of events 9 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	13.0% 3/23 • Number of events 3 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Heartburn (grade 2)	0.00% 0/21 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	4.3% 1/23 • Number of events 2 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Nausea	19.0% 4/21 • Number of events 7 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	17.4% 4/23 • Number of events 4 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Vomiting (Grade 1)	4.8% 1/21 • Number of events 3 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	13.0% 3/23 • Number of events 3 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Vomiting (Grade 2)	0.00% 0/21 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	4.3% 1/23 • Number of events 2 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Abdominal Pain (Grade 1)	23.8% 5/21 • Number of events 5 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	8.7% 2/23 • Number of events 4 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Abdominal Pain (Grade 2)	4.8% 1/21 • Number of events 2 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	8.7% 2/23 • Number of events 4 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Flatulence (Grade 1)	42.9% 9/21 • Number of events 17 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	17.4% 4/23 • Number of events 7 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Flatulence (Grade 2)	9.5% 2/21 • Number of events 5 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	8.7% 2/23 • Number of events 3 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Diarrhea (Grade 1)	28.6% 6/21 • Number of events 8 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	30.4% 7/23 • Number of events 11 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Constipation (Grade 1)	14.3% 3/21 • Number of events 3 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	17.4% 4/23 • Number of events 11 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Constipation (Grade 2)	14.3% 3/21 • Number of events 7 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	0.00% 0/23 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Change in Stool Consistency (Grade 1)	0.00% 0/21 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	17.4% 4/23 • Number of events 11 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Increase in Appetite	0.00% 0/21 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	8.7% 2/23 • Number of events 4 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Hyperglycemia (Grade 3)	0.00% 0/21 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	4.3% 1/23 • Number of events 1 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Gastrointestinal disorders Light Headed (Grade 1)	4.8% 1/21 • Number of events 1 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	0.00% 0/23 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.
Nervous system disorders Headache (Grade 1)	9.5% 2/21 • Number of events 2 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.	0.00% 0/23 Participants were asked to report the frequency/severity of gastrointestinal-related symptoms weekly. Adverse event data for the sulforaphane arm is based only on 21 because all data/specimens for one participant (who was ineligible and mistakenly enrolled) was destroyed per Institutional Review Board regulations.