Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Precancerous Conditions

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Neuroprotective Agents

All Drugs and Chemicals

Other Dietary Supplements

Herbal and Botanical

Flavonoid

Epigallocatechin gallate

Antioxidants

Protective Agents

Omega 3 Fatty Acid

Olive

Catechin

Epicatechin

Epigallocatechin

Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day

Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day

Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day

Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day

green tea catechin extract

fish oil

Given olive oil placebo orally 3 times/day

placebo

Given green tea placebo orally 2 times/day

Jackilen Shannon, PhD

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:

* 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.

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

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

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 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.

United States Department of Defense

National Cancer Institute (NCI)

OHSU Knight Cancer Institute

Principal Investigator

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 I (Fish Oil, 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

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

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 III (Fish Oil, 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

Arm IV (Fish Oil Placebo, Green Tea Placebo)

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Benign

Prostate Cancer

Prostatic Intraepithelial Neoplasia (PIN)

Diagnosis

Dr. Jackilen Shannon

Mixed effects model to assess the effect time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on FAS summary scores

PRE data

POST data

Arm I

Fish oil placebo, Green Tea catechin extract

Arm II

Arm III

Arm IV

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.

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

Mixed effects model to assess the effect of time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on Ki-67

Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer	NCT00253643	Precancerous Co... Prostate Cancer	green tea catec... fish oil placebo placebo	21 Years - 120 Years	OHSU Knight Cancer Institute
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer	NCT00253643	Precancerous Co... Prostate Cancer	green tea catec... fish oil placebo placebo	21 Years - 120 Years	OHSU Knight Cancer Institute

Spots Global Cancer Trial Database for green tea catechin extract