- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
Dublin, Ohio, United States, 43016
- OhioHealth Dublin Methodist Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have biopsy proven carcinoma of the prostate
- Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
- Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Not currently be taking tomato carotenoid dietary supplements or "alternative" products (e.g., lycopene supplements, Lyc-O-Mato, saw palmetto); vitamin A and beta-carotene supplements are allowed
- Not be allergic to tomatoes or tomato products
- Have plasma total cholesterol < 200 mg/dL
- Plasma triglycerides < 200 mg/dL
- Have blood urea nitrogen and serum creatinine (BUN/Cr) without clinically significant abnormalities after review by the study physicians
- Liver enzymes without clinically significant abnormalities after review by the study physicians
- Complete blood count (CBC) without clinically significant abnormalities after review by the study physicians
- Prothrombin time (PT) without clinically significant abnormalities after review by the study physicians
- Partial thromboplastin time (PTT) without clinically significant abnormalities after review by the study physicians
- International normalized ratio (INR) without clinically significant abnormalities after review by the study physicians
- Voluntarily agree to participate and sign an informed consent document
- Agree to have prostate biopsy blocks provided to the study for evaluation
- Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
- Agree to follow a low lycopene and phytoene diet
Exclusion Criteria:
- Have an active malignancy other than prostate cancer that requires therapy
- Have a prostate biopsy with less than 5% cancer involvement
- Have a history of traumatic or surgical castration
- Have plasma total cholesterol > 200 mg/dL
- Have plasma triglycerides > 200 mg/dL
- Have a history of uncontrolled pituitary hormone diseases that currently require varying doses of supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring varying doses of hormone administration with the exception of diabetes and osteoporosis
- Are planning to start certain medications after the trial enrollment; no new finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing new prescription medications for urinary outlet obstructive symptoms will result in discontinuing participation in this study; the use of new non-prescription substances to improve urinary tract symptoms will also result in discontinuing participation (i.e. saw palmetto, other herbal, alternative products); men who are currently taking finasteride or medications (meds) for urinary outlet obstructive symptoms may enroll in the study as long as there is no plan to change the dose in the weeks prior to surgery
- Have a known allergy to tomatoes or have never consumed tomatoes
- Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, Celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
- Have significant loss of gastrointestinal organs, except for appendix, due to surgery
- Have altered immunity such as autoimmune disorders, clinically significant anemia, hemophilia, and blood dyscrasias
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group I (control, no juice)
Patients consume no tomato juice.
|
|
Experimental: Group II (tangerine tomato juice)
Patients will consume two 5.5 oz.
cans of tangerine tomato juice every day until their scheduled surgery.
(approximately 4 weeks)
|
Group II will consume two 5.5 oz.
cans of tangerine tomato juice every day until their scheduled surgery.
(approximately 4 weeks).
Other Names:
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 Names:
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.
Other Names:
|
Experimental: Group III (red tomato juice)
Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
|
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 Names:
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.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of toxicity
Time Frame: Up to time of surgery
|
Up to time of surgery
|
|
Compliance of daily consumption of tangerine tomato juice or red tomato juice
Time Frame: Up to time of surgery
|
Up to time of surgery
|
|
Differences in carotenoid levels of biological samples between groups
Time Frame: Up to time of surgery
|
Linear regression analysis will be used to examine differences in carotenoid levels of biological samples between groups.
|
Up to time of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in histopathologic markers between the treatment groups
Time Frame: Baseline to time of surgery
|
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
Time Frame: Baseline to time of surgery
|
Compared via 3 way ANOVA with pairwise comparisons, or nonparametric Kruskal-Wallis tests where appropriate.
|
Baseline to time of surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven Schwartz, Ph.D., Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-13166
- NCI-2014-01002 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage I Prostate Cancer
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingGynecologic Cancer | Stage I Breast Cancer | Stage II Breast Cancer | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage III Breast Cancer | Stage III Gynecologic Cancer | Stage III Colorectal Cancer | Stage I Colorectal Cancer | Stage II Colorectal Cancer | Stage I Gynecologic... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedProstate Adenocarcinoma | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
National Cancer Institute (NCI)CompletedProstate Adenocarcinoma | Stage I Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
National Cancer Institute (NCI)CompletedStage I Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyTerminatedRecurrent Prostate Carcinoma | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedStage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on dietary intervention (tangerine tomato juice)
-
Ohio State UniversityActive, not recruitingCarotenoid and Flavonoid AbsorptionUnited States
-
USDA Beltsville Human Nutrition Research CenterTerminated
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedProstate CarcinomaUnited States
-
University of BarcelonaRecruitingCognitive Function | Healthy Lifestyle | MicrobiotaSpain
-
Ohio State University Comprehensive Cancer CenterCompletedProstate CancerUnited States
-
University of AarhusCompletedChronic Obstructive Pulmonary Disease ModerateDenmark
-
USDA Beltsville Human Nutrition Research CenterCompleted
-
Royal College of Surgeons, IrelandUniversity College Dublin; Connolly Hospital BlanchardstownCompletedHypertension