Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer
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.
Dietary Supplement: lycopene supplement
Dietary Supplement: fish oil supplement
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Molecular Effects of Nutrition Supplements (MENS) Prostate Study|
- Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2 [ Time Frame: baseline through 3 month ] [ Designated as safety issue: No ]Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.
|Study Start Date:||April 2003|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Active Comparator: lycopene supplement
Two 15mg lycopene capsules daily for 3 months.
|Dietary Supplement: lycopene supplement|
Active Comparator: fish oil supplement
1g fish oil capsule daily for 3 months.
|Dietary Supplement: fish oil supplement|
Placebo Comparator: placebo
placebos for lycopene and fish oil.
- 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.
- 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 servings/week], low fish [< 2 servings/week] vs low tomato, high fish [≥ 2 servings/week] vs high tomato [≥ 4 servings/week], 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402285
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Peter R. Carroll, MD||University of California, San Francisco|