NCT02144649

Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery

A Comparison of Tangerine and Red Tomato Juice in Men With Prostate Cancer: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	dietary intervention (tangerine tomato juice)	Group II will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks).
DIETARY_SUPPLEMENT	dietary intervention (red tomato juice)	Group III will consume two 5.5 oz. cans of red tomato juice every day until their scheduled surgery (approximately 4 weeks).red tomato juice
OTHER	questionnaire administration	Men enrolled in the study will be asked to complete a 3-Day Food Record and a series of additional questionnaires (urologic symptom and quality of life questionnaire) at home.
OTHER	Correlative studies	Blood and urine samples at enrollment and blood, urine, and prostate tissue at the time of surgery to determine compliance with the intervention product and tomato phytochemical biodistribution. Additionally, we will correlate each type of tomato juice with lycopene presence in plasma, urine, and tissue provided by subjects on the day of surgery.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-09-22
• Completion: 2016-09-22
• First posted: 2014-05-22
• Last updated: 2019-08-30

Locations

2 sites across 1 country: United States