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| ID | Type | Description | Link |
|---|---|---|---|
| 6969 | Other Identifier | FHCRC |
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| Name | Class |
|---|---|
| VA Puget Sound Health Care System | FED |
| Seattle Institute for Biomedical and Clinical Research | OTHER |
| Johns Hopkins University | OTHER |
| University of Washington |
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The investigators proposed to identify the biological effects of a high-sulforaphane broccoli sprout extract in normal prostate tissue.
The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Sulforaphane Extract | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Sulforaphane Extract (Broccoli Sprout Extract) | Drug | 100 umol sulforaphane, every other day for 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gene Expression of Phase II Enzymes | Change in Phase II enzyme expression | Baseline and 5 weeks |
| Lipid Oxidation | Blood F2 Isoprostane levels | Baseline and 5 weeks |
| DNA Oxidation | Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels | Five weeks |
| DHT Levels | Change in serum dihydrotestosterone (DHT) levels | Baseline and 5 weeks |
| Testosterone Levels | Change in testosterone (T) levels | Baseline and 5 weeks |
| 3-alpha-diol Gluconate Levels | Change in serum 3-alpha-diol gluconate(3α-DG) levels | Baseline and 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel W Lin, MD | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound | Seattle | Washington | 98108 | United States |
There were no pre-assignment events. Group assignment occurred at the time of participant enrollment.
Recruitment occurred from July 2010 to April 2014 at the VA Puget Sound Health Care System.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulforaphane | High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks |
| FG001 | Placebo | Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulforaphane | High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks |
| BG001 | Placebo | Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gene Expression of Phase II Enzymes | Change in Phase II enzyme expression | Due to budget restrictions, outcome data from only collected from the first 20 participants | Posted | Mean | Standard Deviation | -fold change in expression | Baseline and 5 weeks |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulforaphane | High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burping (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment | Grade 1: Symptomatic but not interfering with activities of daily living daily living |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Lin | Fred Hutchinson Cancer Research Center | 206-221-0797 | dwlin@uw.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| Cedars-Sinai Medical Center | OTHER |
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| Microcrystalline Cellulose NF (placebo) | Drug | 250 mg every other day for 6 weeks |
|
| Procedure cancelled/discontinued |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Lipid Oxidation | Blood F2 Isoprostane levels | Outcome data were not collected due to budget restrictions | Posted | Baseline and 5 weeks |
|
|
| Primary | DNA Oxidation | Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels | Outcome data were not collected due to budget restrictions | Posted | Five weeks |
|
|
| Primary | DHT Levels | Change in serum dihydrotestosterone (DHT) levels | Due to budget restrictions, outcome data from only collected from the first 25 participants | Posted | Mean | Standard Deviation | pg/mL | Baseline and 5 weeks |
|
|
|
| Primary | Testosterone Levels | Change in testosterone (T) levels | Due to budget restrictions, outcome data from only collected from the first 25 participants | Posted | Mean | Standard Deviation | ng/dL | Baseline and 5 weeks |
|
|
|
| Primary | 3-alpha-diol Gluconate Levels | Change in serum 3-alpha-diol gluconate(3α-DG) levels | Due to budget restrictions, outcome data from only collected from the first 25 participants | Posted | Mean | Standard Deviation | ng/mL | Baseline and 5 weeks |
|
|
|
| 0 |
| 21 |
| 19 |
| 21 |
| EG001 | Placebo | Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks | 0 | 23 | 18 | 23 |
|
| Burping (Grade 2) | Gastrointestinal disorders | Non-systematic Assessment | Grade 2: Symptomatic and interfering with activities of |
|
| Abdominal Bloating (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment | Grade 1: No change in bowel function or oral intake |
|
| Abdominal bloating (Grade 2) | Gastrointestinal disorders | Non-systematic Assessment | Grade 2: Symptomatic decreased oral intake; change in bowel function |
|
| Heartburn (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Heartburn (grade 2) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting (Grade 2) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain (Grade 2) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence (Grade 2) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation (Grade 2) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Change in Stool Consistency (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increase in Appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hyperglycemia (Grade 3) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Light Headed (Grade 1) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache (Grade 1) | Nervous system disorders | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |