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Stage I Prostate CancerNCT02144649

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

A study testing dietary intervention (tangerine tomato juice), dietary intervention (red tomato juice) and questionnaire administration in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older, men only
What is being tested?
dietary intervention (tangerine tomato juice), dietary intervention (red tomato juice) and questionnaire administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesUnited States
Study dates
Jun 2015to 22 Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

    Columbus, Ohio, 43210

  • OhioHealth Dublin Methodist Hospital

    Dublin, Ohio, 43016

Other trials in United States

About this study

Official title: A Comparison of Tangerine and Red Tomato Juice in Men With Prostate Cancer: A Pilot Study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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).

Being tested
dietary intervention (tangerine tomato juice), dietary intervention (red tomato juice), questionnaire administration, Correlative studies
Keywords
Prostate Cancer, Tangerine Juice, Tomato Juice
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dietary intervention (tangerine tomato juice)Dietary supplement

    Also called Dietary Modification, intervention, dietary

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

  • dietary intervention (red tomato juice)Dietary supplement

    Also called Dietary Modification, intervention, dietary

    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

  • questionnaire administrationOther

    Also called Ancillary studiesAll

    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.

  • Correlative studiesOther

    Also called laboratory biomarker analysis

    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.

Study groups in NCT02144649
Study groupRoleWhat they receive
Group I (control, no juice)No interventionPatients consume no tomato juice.
Group II (tangerine tomato juice)ExperimentalPatients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)
Receives: Dietary Supplement: dietary intervention (tangerine tomato juice); Other: questionnaire administration; Other: Correlative studies
Group III (red tomato juice)ExperimentalPatients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
Receives: Dietary Supplement: dietary intervention (red tomato juice); Other: questionnaire administration; Other: Correlative studies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of toxicity

    Measured: Up to time of surgery

  2. Compliance of daily consumption of tangerine tomato juice or red tomato juice

    Measured: Up to time of surgery

  3. 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.

    Measured: Up to time of surgery

Secondary outcomes (2)

  1. 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.

    Measured: Baseline to time of surgery

  2. Change in immunohistochemical markers between the treatment groups

    Compared via 3 way ANOVA with pairwise comparisons, or nonparametric Kruskal-Wallis tests where appropriate.

    Measured: Baseline to time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2014 (estimated)
  2. Study startJun 2015
  3. Primary completion22 Sep 2016
  4. Study completion22 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144649
Sponsor's protocol ID
OSU-13166
Other IDs
NCI-2014-01002
Status last verified
Aug 2019
First submitted
20 May 2014
Last updated
30 Aug 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing dietary intervention (tangerine tomato juice), dietary intervention (red tomato juice) and questionnaire administration in people with Stage I Prostate Cancer and Stage IIA Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of toxicity (time frame: Up to time of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.

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