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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01002 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Riverside Methodist Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (control, no juice) | No Intervention | Patients consume no tomato juice. | |
| Group II (tangerine tomato juice) | Experimental | Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks) |
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| Group III (red tomato juice) | Experimental | Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary intervention (tangerine tomato juice) | Dietary Supplement | Group II will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of toxicity | Up to time of surgery | |
| Compliance of daily consumption of tangerine tomato juice or red tomato juice | Up to time of surgery | |
| Differences in carotenoid levels of biological samples between groups | Linear regression analysis will be used to examine differences in carotenoid levels of biological samples between groups. | Up to time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in histopathologic markers between the treatment groups | Compared via 3 way analysis of variance (ANOVA) with pairwise comparisons or nonparametric Kruskal-Wallis tests where appropriate. | Baseline to time of surgery |
| Change in immunohistochemical markers between the treatment groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Schwartz, Ph.D. | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| dietary intervention (red tomato juice) | Dietary Supplement | 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 |
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| questionnaire administration | Other | 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. |
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| Correlative studies | Other | 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. |
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Compared via 3 way ANOVA with pairwise comparisons, or nonparametric Kruskal-Wallis tests where appropriate. |
| Baseline to time of surgery |
| OhioHealth Dublin Methodist Hospital | Dublin | Ohio | 43016 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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