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A Comparison of Tangerine and Red Tomato Juice in Men With Prostate Cancer: A Pilot Study
This randomized pilot clinical trial compares tangerine and red tomato juice in treating patients with prostate cancer undergoing surgery. A diet high in lycopene, a substance found in tomatoes, may help prevent normal cells from transforming into cancer cells in patients with prostate cancer.
PRIMARY OBJECTIVES: I. To conduct a randomized, three-arm pilot clinical trial to determine compliance and safety of daily consumption of tangerine tomato juice or red tomato juice. SECONDARY OBJECTIVES: I. To quantify total carotenoids, total lycopene (LYC), cis-LYC, trans-LYC, phytoene, phytofluene, and lycopene metabolites in plasma and prostate tissue in the three groups of men. II. To evaluate serum biomarkers related to prostate carcinogenesis, including those previously impacted by tomato phytochemicals (testosterone, sex hormone-binding protein \[SHBP\], insulin-like growth factor \[IGF\]-I, IGF-binding protein \[BP\]3, vascular endothelial growth factor \[VEGF\], and a panel of anti-inflammatory cytokines) by validated assays. III. To evaluate molecular signatures using the 200 gene quantitative Nano-string nCounter code set (selected genes known to be impacted by dietary components, genes impacted by common prostate genetic and epigenetic damage, and those regulated by testosterone) and micro-ribonucleic acid (RNA) nCounter code set. IV. To plot the distribution of carotenoid metabolites across the matrix versus the epithelium and cancer versus non-cancer areas of the prostate using matrix-assisted laser desorption ionization (MALDI) imaging of a limited number of samples. OUTLINE: Patients are randomized to 1 of 3 treatment groups. GROUP I: Patients consume no tomato juice. GROUP II: Patients consume two cans of tangerine tomato juice daily until their scheduled surgery (approximately 4 weeks). GROUP III: Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
Age
21 - No limit years
Sex
MALE
Healthy Volunteers
No
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
OhioHealth Dublin Methodist Hospital
Dublin, Ohio, United States
Start Date
June 1, 2015
Primary Completion Date
September 22, 2016
Completion Date
September 22, 2016
Last Updated
August 30, 2019
45
ACTUAL participants
dietary intervention (tangerine tomato juice)
DIETARY_SUPPLEMENT
dietary intervention (red tomato juice)
DIETARY_SUPPLEMENT
questionnaire administration
OTHER
Correlative studies
OTHER
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
NCT05334069
NCT06205316
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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