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Effects of Sulforaphane on Normal Prostate Tissue (PHASE)

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ClinicalTrials.gov Identifier: NCT00946309
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Johns Hopkins University
University of Washington
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Daniel Lin, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Prostate Cancer
Interventions Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
Drug: Microcrystalline Cellulose NF (placebo)
Enrollment 45
Recruitment Details Recruitment occurred from July 2010 to April 2014 at the VA Puget Sound Health Care System.
Pre-assignment Details There were no pre-assignment events. Group assignment occurred at the time of participant enrollment.
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
Period Title: Overall Study
Started 22 23
Completed 21 19
Not Completed 1 4
Reason Not Completed
Protocol Violation             1             0
Lost to Follow-up             0             1
Procedure cancelled/discontinued             0             3
Arm/Group Title Sulforaphane Placebo Total
Hide Arm/Group Description High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks Total of all reporting groups
Overall Number of Baseline Participants 22 23 45
Hide Baseline Analysis Population Description
One participant enrolled to the placebo arm was determined to be ineligible, and was withdrawn from the study Two additional participants enrolled to the placebo arm became ineligible after enrollment, and were withdrawn from the study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  54.5%
17
  73.9%
29
  64.4%
>=65 years
10
  45.5%
6
  26.1%
16
  35.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 23 participants 45 participants
62.6  (5.4) 62.8  (4.3) 62.7  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
22
 100.0%
23
 100.0%
45
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
Hispanic or Latino
0
   0.0%
1
   4.3%
1
   2.2%
Not Hispanic or Latino
22
 100.0%
22
  95.7%
44
  97.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   4.5%
0
   0.0%
1
   2.2%
Black or African American
4
  18.2%
3
  13.0%
7
  15.6%
White
16
  72.7%
20
  87.0%
36
  80.0%
More than one race
1
   4.5%
0
   0.0%
1
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 23 participants 45 participants
22 23 45
1.Primary Outcome
Title Gene Expression of Phase II Enzymes
Hide Description Change in Phase II enzyme expression
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to budget restrictions, outcome data from only collected from the first 20 participants
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:
High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: -fold change in expression
Glutathione peroxidase 4 (GPX4) expression -0.36  (2.0) 0.26  (1.1)
Glutathione S-transferase A2 (GSTa2) expression 0.15  (4.1) -0.59  (3.0)
NAD(P)H:quinone oxidoreductase (NQ01) expression -0.02  (1.3) 0.42  (0.10)
RODH5 F2/R2 expression -0.10  (2.6) -0.02  (2.6)
Superoxide dismutase (SOD1) expression 0.35  (1.1) 0.5  (1.0)
2.Primary Outcome
Title Lipid Oxidation
Hide Description Blood F2 Isoprostane levels
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data were not collected due to budget restrictions
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:
High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title DNA Oxidation
Hide Description Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
Time Frame Five weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data were not collected due to budget restrictions
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:
High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title DHT Levels
Hide Description Change in serum dihydrotestosterone (DHT) levels
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to budget restrictions, outcome data from only collected from the first 25 participants
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:
High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
2.09  (77.8) 19.33  (98.0)
5.Primary Outcome
Title Testosterone Levels
Hide Description Change in testosterone (T) levels
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to budget restrictions, outcome data from only collected from the first 25 participants
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:
High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: ng/dL
-36.79  (79.1) 5.75  (156.8)
6.Primary Outcome
Title 3-alpha-diol Gluconate Levels
Hide Description Change in serum 3-alpha-diol gluconate(3α-DG) levels
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to budget restrictions, outcome data from only collected from the first 25 participants
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description:
High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
-0.69  (1.6) 0.39  (1.2)
Time Frame [Not Specified]
Adverse Event Reporting Description

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.

 
Arm/Group Title Sulforaphane Placebo
Hide Arm/Group Description High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
All-Cause Mortality
Sulforaphane Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Sulforaphane Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/23 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sulforaphane Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/21 (90.48%)      18/23 (78.26%)    
Gastrointestinal disorders     
Burping (Grade 1) * [1]  4/21 (19.05%)  8 6/23 (26.09%)  6
Burping (Grade 2) * [2]  1/21 (4.76%)  3 0/23 (0.00%)  0
Abdominal Bloating (Grade 1) * [3]  5/21 (23.81%)  6 3/23 (13.04%)  3
Abdominal bloating (Grade 2) * [4]  1/21 (4.76%)  3 0/23 (0.00%)  0
Heartburn (Grade 1) *  5/21 (23.81%)  9 3/23 (13.04%)  3
Heartburn (grade 2) *  0/21 (0.00%)  0 1/23 (4.35%)  2
Nausea *  4/21 (19.05%)  7 4/23 (17.39%)  4
Vomiting (Grade 1) *  1/21 (4.76%)  3 3/23 (13.04%)  3
Vomiting (Grade 2) *  0/21 (0.00%)  0 1/23 (4.35%)  2
Abdominal Pain (Grade 1) *  5/21 (23.81%)  5 2/23 (8.70%)  4
Abdominal Pain (Grade 2) *  1/21 (4.76%)  2 2/23 (8.70%)  4
Flatulence (Grade 1) *  9/21 (42.86%)  17 4/23 (17.39%)  7
Flatulence (Grade 2) *  2/21 (9.52%)  5 2/23 (8.70%)  3
Diarrhea (Grade 1) *  6/21 (28.57%)  8 7/23 (30.43%)  11
Constipation (Grade 1) *  3/21 (14.29%)  3 4/23 (17.39%)  11
Constipation (Grade 2) *  3/21 (14.29%)  7 0/23 (0.00%)  0
Change in Stool Consistency (Grade 1) *  0/21 (0.00%)  0 4/23 (17.39%)  11
Increase in Appetite *  0/21 (0.00%)  0 2/23 (8.70%)  4
Hyperglycemia (Grade 3) *  0/21 (0.00%)  0 1/23 (4.35%)  1
Light Headed (Grade 1) *  1/21 (4.76%)  1 0/23 (0.00%)  0
Nervous system disorders     
Headache (Grade 1) *  2/21 (9.52%)  2 0/23 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Grade 1: Symptomatic but not interfering with activities of daily living daily living
[2]
Grade 2: Symptomatic and interfering with activities of
[3]
Grade 1: No change in bowel function or oral intake
[4]
Grade 2: Symptomatic decreased oral intake; change in bowel function
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. Daniel Lin
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-221-0797
EMail: dwlin@uw.edu
Layout table for additonal information
Responsible Party: Daniel Lin, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00946309    
Other Study ID Numbers: PHS 2333.00
6969 ( Other Identifier: FHCRC )
First Submitted: July 23, 2009
First Posted: July 27, 2009
Results First Submitted: August 20, 2015
Results First Posted: November 15, 2016
Last Update Posted: November 15, 2016