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

Primary Purpose

Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dietary intervention (tangerine tomato juice)
dietary intervention (red tomato juice)
questionnaire administration
Correlative studies
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Prostate Cancer focused on measuring Prostate Cancer, Tangerine Juice, Tomato Juice

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • OhioHealth Dublin Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group I (control, no juice)

Group II (tangerine tomato juice)

Group III (red tomato juice)

Arm Description

Patients consume no tomato juice.

Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)

Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).

Outcomes

Primary Outcome Measures

Incidence of toxicity
Compliance of daily consumption of tangerine tomato juice or red tomato juice
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.

Secondary Outcome Measures

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.
Change in immunohistochemical markers between the treatment groups
Compared via 3 way ANOVA with pairwise comparisons, or nonparametric Kruskal-Wallis tests where appropriate.

Full Information

First Posted
May 20, 2014
Last Updated
August 29, 2019
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
Riverside Methodist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02144649
Brief Title
Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery
Official Title
A Comparison of Tangerine and Red Tomato Juice in Men With Prostate Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 22, 2016 (Actual)
Study Completion Date
September 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
Riverside Methodist Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
Keywords
Prostate Cancer, Tangerine Juice, Tomato Juice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (control, no juice)
Arm Type
No Intervention
Arm Description
Patients consume no tomato juice.
Arm Title
Group II (tangerine tomato juice)
Arm Type
Experimental
Arm Description
Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)
Arm Title
Group III (red tomato juice)
Arm Type
Experimental
Arm Description
Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary intervention (tangerine tomato juice)
Other Intervention Name(s)
Dietary Modification, intervention, dietary
Intervention Description
Group II will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks).
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary intervention (red tomato juice)
Other Intervention Name(s)
Dietary Modification, intervention, dietary
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Other Intervention Name(s)
Ancillary studiesAll
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Correlative studies
Other Intervention Name(s)
laboratory biomarker analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of toxicity
Time Frame
Up to time of surgery
Title
Compliance of daily consumption of tangerine tomato juice or red tomato juice
Time Frame
Up to time of surgery
Title
Differences in carotenoid levels of biological samples between groups
Description
Linear regression analysis will be used to examine differences in carotenoid levels of biological samples between groups.
Time Frame
Up to time of surgery
Secondary Outcome Measure Information:
Title
Change in histopathologic markers between the treatment groups
Description
Compared via 3 way analysis of variance (ANOVA) with pairwise comparisons or nonparametric Kruskal-Wallis tests where appropriate.
Time Frame
Baseline to time of surgery
Title
Change in immunohistochemical markers between the treatment groups
Description
Compared via 3 way ANOVA with pairwise comparisons, or nonparametric Kruskal-Wallis tests where appropriate.
Time Frame
Baseline to time of surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Schwartz, Ph.D.
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OhioHealth Dublin Methodist Hospital
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

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

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