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

NCT02144649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-08-30

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Riverside Methodist Hospital

    collaborator OTHER

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Steven Schwartz, Ph.D. · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-09-22
Completion
2016-09-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144649 on ClinicalTrials.gov