Trial Outcomes & Findings for Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer (NCT NCT00253643)

Last Updated: 2017-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

89 participants

Primary outcome timeframe

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)

Results posted on

2017-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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	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
Overall Study STARTED	14	15	29	31
Overall Study COMPLETED	14	15	28	28
Overall Study NOT COMPLETED	0	0	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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	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
Overall Study Withdrawal by Subject	0	0	1	1
Overall Study Non-Compliance	0	0	0	2

Baseline Characteristics

Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Fish Oil, Green Tea Catechin Extract) n=14 Participants 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	Arm II (Fish Oil Placebo, Green Tea Catechin Extract) n=15 Participants 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	Arm III (Fish Oil, Green Tea Placebo) n=28 Participants 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	Arm IV (Fish Oil Placebo, Green Tea Placebo) n=28 Participants 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	Total n=85 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	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants	19 Participants n=483 Participants	55 Participants n=36 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants	9 Participants n=483 Participants	30 Participants n=36 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	15 Participants n=4 Participants	28 Participants n=27 Participants	28 Participants n=483 Participants	85 Participants n=36 Participants
Region of Enrollment United States	14 participants n=93 Participants	15 participants n=4 Participants	28 participants n=27 Participants	28 participants n=483 Participants	85 participants n=36 Participants
Diagnosis Benign	9 participants n=93 Participants	11 participants n=4 Participants	16 participants n=27 Participants	21 participants n=483 Participants	57 participants n=36 Participants
Diagnosis Prostate Cancer	2 participants n=93 Participants	1 participants n=4 Participants	6 participants n=27 Participants	6 participants n=483 Participants	15 participants n=36 Participants
Diagnosis Prostatic Intraepithelial Neoplasia (PIN)	3 participants n=93 Participants	3 participants n=4 Participants	6 participants n=27 Participants	1 participants n=483 Participants	13 participants n=36 Participants

PRIMARY outcome

Timeframe: 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)

Population: 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.

Outcome measures

Outcome measures
Measure	Arm I n=14 Participants Fish oil, Green Tea catechin extract	Arm II n=15 Participants Fish oil placebo, Green Tea catechin extract	Arm III n=28 Participants Fish oil, Green Tea placebo	Arm IV n=28 Participants Fish oil placebo, Green Tea placebo
Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) PRE data	147 units on a scale Standard Deviation 98.6	158.8 units on a scale Standard Deviation 84.6	138.3 units on a scale Standard Deviation 63.8	102.3 units on a scale Standard Deviation 85.9
Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) POST data	140.7 units on a scale Standard Deviation 100.3	159.3 units on a scale Standard Deviation 75.5	145.2 units on a scale Standard Deviation 72.2	152.2 units on a scale Standard Deviation 80.9

PRIMARY outcome

Timeframe: End of study

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.

Outcome measures

Outcome measures
Measure	Arm I n=14 Participants Fish oil, Green Tea catechin extract	Arm II n=15 Participants Fish oil placebo, Green Tea catechin extract	Arm III n=28 Participants Fish oil, Green Tea placebo	Arm IV n=28 Participants Fish oil placebo, Green Tea placebo
Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention	18.5 %age of cells & nuclei stained Interval 1.0 to 55.0	8 %age of cells & nuclei stained Interval 2.0 to 52.0	10 %age of cells & nuclei stained Interval 0.0 to 45.0	12 %age of cells & nuclei stained Interval 1.0 to 50.0

Adverse Events

Arm I (Fish Oil, Green Tea Catechin Extract)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm II (Fish Oil Placebo, Green Tea Catechin Extract)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm III (Fish Oil, Green Tea Placebo)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm IV (Fish Oil Placebo, Green Tea Placebo)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I (Fish Oil, Green Tea Catechin Extract) n=14 participants at risk 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	Arm II (Fish Oil Placebo, Green Tea Catechin Extract) n=15 participants at risk 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	Arm III (Fish Oil, Green Tea Placebo) n=29 participants at risk 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	Arm IV (Fish Oil Placebo, Green Tea Placebo) n=31 participants at risk 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
Gastrointestinal disorders Bloating (grade 2)	0.00% 0/14 • 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.	0.00% 0/15 • 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.	0.00% 0/29 • 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.	3.2% 1/31 • 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.
Musculoskeletal and connective tissue disorders Muscle Pain (grade 2)	7.1% 1/14 • 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.	6.7% 1/15 • 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.	0.00% 0/29 • 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.	3.2% 1/31 • 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.
Gastrointestinal disorders Gas/Flatulence (grade 2)	0.00% 0/14 • 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.	6.7% 1/15 • 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.	3.4% 1/29 • 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.	0.00% 0/31 • 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.
Gastrointestinal disorders Burping (grade 2)	0.00% 0/14 • 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.	6.7% 1/15 • 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.	0.00% 0/29 • 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.	3.2% 1/31 • 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.
Gastrointestinal disorders Nausea/Vomiting (grade 2)	0.00% 0/14 • 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.	6.7% 1/15 • 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.	3.4% 1/29 • 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.	0.00% 0/31 • 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.
Skin and subcutaneous tissue disorders Bruising (grade 2)	0.00% 0/14 • 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.	6.7% 1/15 • 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.	3.4% 1/29 • 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.	3.2% 1/31 • 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.
Nervous system disorders Headache (grade 2)	0.00% 0/14 • 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.	0.00% 0/15 • 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.	6.9% 2/29 • 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.	3.2% 1/31 • 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.
Gastrointestinal disorders Upset Stomach (grade 2)	0.00% 0/14 • 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.	0.00% 0/15 • 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.	3.4% 1/29 • 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.	3.2% 1/31 • 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.
Gastrointestinal disorders Diarrhea/ Loose Stool (grade 2)	0.00% 0/14 • 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.	0.00% 0/15 • 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.	3.4% 1/29 • 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.	0.00% 0/31 • 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.
Gastrointestinal disorders Heartburn (grade 2)	0.00% 0/14 • 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.	0.00% 0/15 • 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.	0.00% 0/29 • 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.	3.2% 1/31 • 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.

Additional Information

Dr. Jackilen Shannon

Oregon Health & Science University

Phone: 503-220-8262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place