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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA069533 | U.S. NIH Grant/Contract | View source | |
| OHSU-CI-CPC-04131-LX | Other Identifier | OHSU Knight Cancer Institute number | |
| VAMC-04-0303/ M1016 | Other Identifier | Portland VA IRB number | |
| DOD-W81XWH-04-1-0296 | Other Grant/Funding Number | Dept of Defense Award Number | |
| OHSU-1117 | Other Identifier | OHSU IRB number | |
| KPNW-NW-05SLIEB-01 | Other Identifier | Kaiser Permanente NW IRB number |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fish oil and/or green tea may prevent prostate cancer.
PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (under 65 vs 65 and over). Patients are randomized to 1 of 4 treatment arms.
Treatment in one of the above-listed arms continues for up to 20 weeks in the absence of disease progression or unacceptable toxicity.
All patients undergo a prostate biopsy on the last day of study treatment.
After completion of study treatment, patients receive a follow-up phone call at/around 30 days later.
PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (FO, GT catechin extract) | Experimental | Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day |
|
| ArmII (FO placebo, GT catechin extract) | Experimental | Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day |
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| Arm III (FO, GT placebo) | Experimental | Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day |
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| Arm IV (FO placebo, GT placebo) | Placebo Comparator | Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| green tea catechin extract | Dietary Supplement | Given orally 2 times/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) | Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300. | Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention) |
| Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention | Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values. | End of study |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Jackilen Shannon, PhD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Center for Health Research | Portland | Oregon | 97227 | United States | ||
| OHSU Knight Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27646578 | Derived | Zhang Z, Garzotto M, Beer TM, Thuillier P, Lieberman S, Mori M, Stoller WA, Farris PE, Shannon J. Effects of omega-3 Fatty Acids and Catechins on Fatty Acid Synthase in the Prostate: A Randomized Controlled Trial. Nutr Cancer. 2016 Nov-Dec;68(8):1309-1319. doi: 10.1080/01635581.2016.1224365. Epub 2016 Sep 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Fish Oil, Green Tea Catechin Extract) | Patients receive oral fish oil 3/day and oral green tea extract 2/day green tea catechin extract: Given orally 2 times/day fish oil: Given orally 3 times/day laboratory biomarker analysis: Correlative studies questionnaire administration: Ancillary studies |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| fish oil | Dietary Supplement | Given orally 3 times/day |
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| placebo | Other | Given olive oil placebo orally 3 times/day |
|
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| placebo | Other | Given green tea placebo orally 2 times/day |
|
|
| Portland |
| Oregon |
| 97239-3098 |
| United States |
| Veterans Affairs Medical Center - Portland | Portland | Oregon | 97239 | United States |
| Arm II (Fish Oil Placebo, Green Tea Catechin Extract) |
Patients receive an oil placebo 3/day and oral green tea extract 2/day green tea catechin extract: Given orally 2 times/day placebo: Given olive oil placebo orally 3 times/day laboratory biomarker analysis: Correlative studies questionnaire administration: Ancillary studies |
| FG002 | Arm III (Fish Oil, Green Tea Placebo) | Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day fish oil: Given orally 3 times/day placebo: Given green tea placebo orally 2 times/day laboratory biomarker analysis: Correlative studies questionnaire administration: Ancillary studies |
| FG003 | Arm IV (Fish Oil Placebo, Green Tea Placebo) | Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day placebo: Given olive oil placebo orally 3 times/day placebo: Given green tea placebo orally 2 times/day laboratory biomarker analysis: Correlative studies questionnaire administration: Ancillary studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Fish Oil, Green Tea Catechin Extract) | Patients receive oral fish oil 3/day and oral green tea extract 2/day green tea catechin extract: Given orally 2 times/day fish oil: Given orally 3 times/day |
| BG001 | Arm II (Fish Oil Placebo, Green Tea Catechin Extract) | Patients receive an oil placebo 3/day and oral green tea extract 2/day green tea catechin extract: Given orally 2 times/day placebo: Given olive oil placebo orally 3 times/day |
| BG002 | Arm III (Fish Oil, Green Tea Placebo) | Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day fish oil: Given orally 3 times/day placebo: Given green tea placebo orally 2 times/day |
| BG003 | Arm IV (Fish Oil Placebo, Green Tea Placebo) | Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day placebo: Given olive oil placebo orally 3 times/day placebo: Given green tea placebo orally 2 times/day |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diagnosis | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) | Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300. | Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention) |
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| Primary | Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention | Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values. | Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted. | Posted | Median | Full Range | %age of cells & nuclei stained | End of study |
|
Adverse event data were collected every month the subject was on study via questionnaire over the phone. We conducted a 30-day follow-up phone call and utilized our adverse event questionnaire to capture this information at baseline as well.
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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 | Arm I (Fish Oil, Green Tea Catechin Extract) | Patients receive oral fish oil 3/day and oral green tea extract 2/day green tea catechin extract: Given orally 2 times/day fish oil: Given orally 3 times/day | 0 | 14 | 1 | 14 | ||
| EG001 | Arm II (Fish Oil Placebo, Green Tea Catechin Extract) | Patients receive an oil placebo 3/day and oral green tea extract 2/day green tea catechin extract: Given orally 2 times/day placebo: Given olive oil placebo orally 3 times/day | 0 | 15 | 2 | 15 | ||
| EG002 | Arm III (Fish Oil, Green Tea Placebo) | Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day fish oil: Given orally 3 times/day placebo: Given green tea placebo orally 2 times/day | 0 | 29 | 5 | 29 | ||
| EG003 | Arm IV (Fish Oil Placebo, Green Tea Placebo) | Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day placebo: Given olive oil placebo orally 3 times/day placebo: Given green tea placebo orally 2 times/day | 0 | 31 | 1 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating (grade 2) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle Pain (grade 2) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gas/Flatulence (grade 2) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Burping (grade 2) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea/Vomiting (grade 2) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Bruising (grade 2) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Headache (grade 2) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Upset Stomach (grade 2) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea/ Loose Stool (grade 2) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn (grade 2) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jackilen Shannon | Oregon Health & Science University | 503-220-8262 | 54868 | shannoja@ohsu.edu |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C472086 | polyphenon E |
| D005395 | Fish Oils |
| D015525 | Fatty Acids, Omega-3 |
| D004281 | Docosahexaenoic Acids |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Prostate Cancer |
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| Prostatic Intraepithelial Neoplasia (PIN) |
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| POST data |
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| Units | Counts |
|---|---|
| Participants |
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