Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00402285|
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : May 16, 2013
Last Update Posted : January 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: lycopene supplement Dietary Supplement: fish oil supplement Other: Placebo||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Molecular Effects of Nutrition Supplements (MENS) Prostate Study|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
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.
placebos for lycopene and fish oil.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|