Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402285
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2006-11-20
Brief Title:
Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
The Molecular Effects of Nutrition Supplements MENS Prostate Study
Status:
COMPLETED
Status Verified Date:
2015-12
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 The use of lycopene a substance found in tomatoes or omega-3 fatty acid nutritional supplements may keep cancer from growing in patients with prostate cancer
PURPOSE This randomized clinical trial is studying lycopene to see how well it works compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II prostate cancer
PURPOSE This randomized clinical trial is studying lycopene to see how well it works compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare gene expression in normal prostate tissue at baseline and after treatment of patients with stage I or II adenocarcinoma of the prostate treated with lycopene vs omega-3 fatty acid nutritional supplements vs placebo
Secondary
Determine new candidate molecular targets for lycopene and omega-3 response pathways
Correlate baseline gene expression patterns determined by cDNA array analysis with self-reported dietary intake
Correlate gene expression patterns with progression or lack of progression at 12 months after study entry
Determine if lycopene or omega-3 supplements affect the incidence of tumor progression
OUTLINE This is a randomized placebo-controlled study Patients are stratified according to dietary intake of tomato and fish low tomato 4 servingsweek low fish 2 servingsweek vs low tomato high fish 2 servingsweek vs high tomato 4 servingsweek low fish vs high tomato high fish Patients are randomized to 1 of 3 treatment arms
Arm I Patients maintain normal diet and receive oral omega-3 fatty acids placebo 3 times daily and lycopene placebo twice daily
Arm II Patients receive oral lycopene twice daily and oral omega-3 fatty acids placebo 3 times daily
Arm III Patients receive oral lycopene placebo twice daily and oral omega-3 fatty acids 3 times daily
In all arms treatment continues for up to 90 days or until post-treatment biopsy is scheduled a maximum of 104 days in the absence of disease progression
Patients complete a dietary questionnaire at baseline and then for 3 days each month during study therapy Quality of life is assessed at baseline and at 3 months
Prostate tissue needle biopsies and blood samples are collected at baseline and at 3 months Tissue and blood samples are examined for lycopene and omega-3 fatty acids treatment compliance omega-6 fatty acids insulin-like growth factor IGF-1 IGF binding protein-5 and cyclooxygenase-2 gene by polymerase chain reaction cDNA microarray hybridization and other gene expression assays
After completion of study treatment patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 114 patients will be enrolled in this study
Primary
Compare gene expression in normal prostate tissue at baseline and after treatment of patients with stage I or II adenocarcinoma of the prostate treated with lycopene vs omega-3 fatty acid nutritional supplements vs placebo
Secondary
Determine new candidate molecular targets for lycopene and omega-3 response pathways
Correlate baseline gene expression patterns determined by cDNA array analysis with self-reported dietary intake
Correlate gene expression patterns with progression or lack of progression at 12 months after study entry
Determine if lycopene or omega-3 supplements affect the incidence of tumor progression
OUTLINE This is a randomized placebo-controlled study Patients are stratified according to dietary intake of tomato and fish low tomato 4 servingsweek low fish 2 servingsweek vs low tomato high fish 2 servingsweek vs high tomato 4 servingsweek low fish vs high tomato high fish Patients are randomized to 1 of 3 treatment arms
Arm I Patients maintain normal diet and receive oral omega-3 fatty acids placebo 3 times daily and lycopene placebo twice daily
Arm II Patients receive oral lycopene twice daily and oral omega-3 fatty acids placebo 3 times daily
Arm III Patients receive oral lycopene placebo twice daily and oral omega-3 fatty acids 3 times daily
In all arms treatment continues for up to 90 days or until post-treatment biopsy is scheduled a maximum of 104 days in the absence of disease progression
Patients complete a dietary questionnaire at baseline and then for 3 days each month during study therapy Quality of life is assessed at baseline and at 3 months
Prostate tissue needle biopsies and blood samples are collected at baseline and at 3 months Tissue and blood samples are examined for lycopene and omega-3 fatty acids treatment compliance omega-6 fatty acids insulin-like growth factor IGF-1 IGF binding protein-5 and cyclooxygenase-2 gene by polymerase chain reaction cDNA microarray hybridization and other gene expression assays
After completion of study treatment patients are followed every 3 months for 2 years
PROJECTED ACCRUAL A total of 114 patients will be enrolled in 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 |
|---|---|---|---|
| UCSF-H5664-22834-04A | None | None | None |
| UCSF-03553 | None | None | None |