NCT02144649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2016

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

May 20, 2014

Last Update Submit

August 29, 2019

Conditions

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

Keywords

Prostate CancerTangerine JuiceTomato Juice

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Change in histopathologic markers between the treatment groups

    Baseline to time of surgery

  • Change in immunohistochemical markers between the treatment groups

    Baseline to time of surgery

Study Arms (3)

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)

Dietary Supplement: dietary intervention (tangerine tomato juice)Other: questionnaire administrationOther: Correlative studies

Group III (red tomato juice)

EXPERIMENTAL

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

Dietary Supplement: dietary intervention (red tomato juice)Other: questionnaire administrationOther: Correlative studies

Interventions

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).

Also known as: Dietary Modification, intervention, dietary
Group II (tangerine tomato juice)
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

Also known as: Dietary Modification, intervention, dietary
Group III (red tomato juice)
questionnaire administrationOTHER

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.

Also known as: Ancillary studiesAll
Group II (tangerine tomato juice)Group III (red tomato juice)
Correlative studiesOTHER

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.

Also known as: laboratory biomarker analysis
Group II (tangerine tomato juice)Group III (red tomato juice)

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Columbus, Ohio, 43210, United States

Location

OhioHealth Dublin Methodist Hospital

Dublin, Ohio, 43016, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Steven Schwartz, Ph.D.

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

June 1, 2015

Primary Completion

September 22, 2016

Study Completion

September 22, 2016

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

US(2)