Precancerous ConditionNCT00253643

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

A study testing green tea catechin extract and fish oil in people with Precancerous Condition and Prostate Cancer, run by OHSU Knight Cancer Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 21 to 120 years, men onlyHealthy volunteers can take part
Conditions the study is for: Precancerous Condition, Prostate Cancer
What is being tested?: green tea catechin extract and fish oil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 3 sitesUnited States
Study dates: Jul 2005to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 120 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate)

Who cannot join

Definitive invasive prostate cancer on initial biopsy
Significant active medical illness that in the opinion of the clinician would preclude protocol treatment.
History of ventricular tachycardia or ventricular fibrillation
Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment
Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial
Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial.

Show all 10Show fewer

Subject reported allergy or sensitivity to fish oil, olive oil or green tea
Subject reported history of hemophilia, van Willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated.
Total bilirubin greater than institutional upper limit of normal
Concurrent high risk study participation

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial

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.

Read the detailed description

OBJECTIVES:

Determine the cancer preventing effects of fish oil supplementation and green tea extract use on markers of alteration in lipid metabolism in prostate tissue samples.

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.

Arm I: Patients receive oral fish oil three times daily and oral green tea extract twice daily.
Arm II: Patients receive an oil placebo three times daily and oral green tea extract twice daily.
Arm III: Patients receive oral fish oil three times daily and a placebo twice daily.
Arm IV: Patients receive an oil placebo three times daily and another placebo twice daily.

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.

Conditions: Precancerous Condition, Prostate Cancer
Being tested: green tea catechin extract, fish oil, placebo
Keywords: prostate cancer, precancerous condition
Medical subject headings: Precancerous Conditions, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

green tea catechin extractDietary supplement
Also called Polyphenon E
Given orally 2 times/day
fish oilDietary supplement
Also called omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA
Given orally 3 times/day
placeboOther
Also called PLCB, olive oil
Given olive oil placebo orally 3 times/day
placeboOther
Also called PLCB
Given green tea placebo orally 2 times/day

Study groups in NCT00253643
Study group	Role	What they receive
Arm I (FO, GT catechin extract)	Experimental	Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day Receives: Dietary Supplement: green tea catechin extract; Dietary Supplement: fish oil
ArmII (FO placebo, GT catechin extract)	Experimental	Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day Receives: Dietary Supplement: green tea catechin extract; Other: placebo
Arm III (FO, GT placebo)	Experimental	Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day Receives: Dietary Supplement: fish oil; Other: placebo
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 Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: End of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Dec 2013

First posted15 Nov 2005 (estimated)
Study startJul 2005
Primary completionSep 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Precancerous ConditionStudies of the same condition, open and under way.
More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00253643
Sponsor's protocol ID: CDR0000443617
Other IDs: P30CA069533, OHSU-CI-CPC-04131-LX, VAMC-04-0303/ M1016, DOD-W81XWH-04-1-0296, OHSU-1117, KPNW-NW-05SLIEB-01
Status last verified: Apr 2017
First submitted: 11 Nov 2005
Last updated: 18 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 27646578

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT00253643
Acronym / sponsor ID: CDR0000443617
Conditions: Precancerous Condition, Prostate Cancer
Keywords: prostate cancer, precancerous condition
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: OHSU Knight Cancer InstituteUniversity, hospital or other
Collaborators: United States Department of Defense, National Cancer Institute (NCI)
Study start: Jul 2005
Primary completion: Sep 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 15 Nov 2005 (estimated)
Results: Posted 18 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

OBJECTIVES:

Determine the cancer preventing effects of fish oil supplementation and green tea extract use on markers of alteration in lipid metabolism in prostate tissue samples.

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.

Arm I: Patients receive oral fish oil three times daily and oral green tea extract twice daily.
Arm II: Patients receive an oil placebo three times daily and oral green tea extract twice daily.
Arm III: Patients receive oral fish oil three times daily and a placebo twice daily.
Arm IV: Patients receive an oil placebo three times daily and another placebo twice daily.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Arm I (FO, GT catechin extract)	Experimental	Dietary Supplement: green tea catechin extract, Dietary Supplement: fish oilPatients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
ArmII (FO placebo, GT catechin extract)	Experimental	Dietary Supplement: green tea catechin extract, Other: placeboPatients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
Arm III (FO, GT placebo)	Experimental	Dietary Supplement: fish oil, Other: placeboPatients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
Arm IV (FO placebo, GT placebo)	Placebo comparator	Other: placeboPatients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day

Who may qualify

Ages: 21 to 120 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate)

Key exclusion criteria (10 listed)

Definitive invasive prostate cancer on initial biopsy
Significant active medical illness that in the opinion of the clinician would preclude protocol treatment.
History of ventricular tachycardia or ventricular fibrillation
Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment
Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
green tea catechin extractAlso: Polyphenon EGiven orally 2 times/day	Dietary supplement	Arm I (FO, GT catechin extract), ArmII (FO placebo, GT catechin extract)
fish oilAlso: omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFAGiven orally 3 times/day	Dietary supplement	Arm I (FO, GT catechin extract), Arm III (FO, GT placebo)
placeboAlso: PLCB, olive oilGiven olive oil placebo orally 3 times/day	Other	Arm III (FO, GT placebo), Arm IV (FO placebo, GT placebo)
placeboAlso: PLCBGiven green tea placebo orally 2 times/day	Other	Arm IV (FO placebo, GT placebo), ArmII (FO placebo, GT catechin extract)

Primary outcome

Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)
Time frame: 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)
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.
Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention
Time frame: 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.

Results and safety

Results posted to the registry on 18 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Fish Oil, Green Tea Catechin Extract)	14	14
Arm II (Fish Oil Placebo, Green Tea Catechin Extract)	15	15
Arm III (Fish Oil, Green Tea Placebo)	29	28
Arm IV (Fish Oil Placebo, Green Tea Placebo)	31	28

Primary outcome: Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)

Time frame: 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). Mean (Standard Deviation). Unit: units on a scale

Measure	Arm I n = 14	Arm II n = 15	Arm III n = 28	Arm IV n = 28
PRE data	147 (98.6)	158.8 (84.6)	138.3 (63.8)	102.3 (85.9)
POST data	140.7 (100.3)	159.3 (75.5)	145.2 (72.2)	152.2 (80.9)

Arm I vs Arm II vs Arm III vs Arm IV: p = 0.1521, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention

Time frame: End of study. Median (Full Range). Unit: %age of cells & nuclei stained

Measure	Arm I n = 14	Arm II n = 15	Arm III n = 28	Arm IV n = 28
Value	18.5 (1 to 55)	8 (2 to 52)	10 (0 to 45)	12 (1 to 50)

Arm I vs Arm II vs Arm III vs Arm IV: p = 0.1573, Mixed Models Analysis

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Fish Oil, Green Tea Catechin Extract)	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
Arm II (Fish Oil Placebo, Green Tea Catechin Extract)	0 of 15 (0%)	2 of 15 (13.3%)	Not reported
Arm III (Fish Oil, Green Tea Placebo)	0 of 29 (0%)	5 of 29 (17.2%)	Not reported
Arm IV (Fish Oil Placebo, Green Tea Placebo)	0 of 31 (0%)	1 of 31 (3.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27646578Zhang 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jackilen Shannon, PhD principal investigator

OHSU Knight Cancer Institute

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing green tea catechin extract and fish oil in people with Precancerous Condition and Prostate Cancer, run by OHSU Knight Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00253643, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.