Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253643
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2005-11-11
Brief Title:
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of fish oil andor green tea may prevent prostate cancer
PURPOSE This randomized clinical trial is studying how well a fish oil andor green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer
PURPOSE This randomized clinical trial is studying how well a fish oil andor green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing 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 ataround 30 days later
PROJECTED ACCRUAL A total of 144 patients will be accrued for this study
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 ataround 30 days later
PROJECTED ACCRUAL A total of 144 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KPNW-NW-05SLIEB-01 | OTHER | Kaiser Permanente NW IRB number | httpsreporternihgovquickSearchP30CA069533 |
| P30CA069533 | NIH | None | None |
| OHSU-CI-CPC-04131-LX | OTHER | None | None |
| VAMC-04-0303 M1016 | OTHER | None | None |
| DOD-W81XWH-04-1-0296 | OTHER_GRANT | None | None |
| OHSU-1117 | OTHER | None | None |