Prostate CancerNCT02292524
Prostate Biomarkers in Men Consuming Tomato Products
A study testing Commercially-available tomato food product in people with Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
Prostate Biomarkers in Men Consuming Tomato Products Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Commercially-available tomato food product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Oct 2004
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have biopsy-proven, clinically localized adenocarcinoma of the prostate based on standard presurgical staging studies
- Have chosen to undergo a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
- Have kidney and liver enzymes, CBC, and PT/PTT/INR within normal limits
- Agree to sign consent form prior to enrollment in the study
- Exclusion Criteria: Men may not participate in this if they:
- Are currently taking lycopene or "alternative" dietary supplements
- Have a history of digestive or malabsorptive disorders, metabolic enzyme deficiencies, or other disorders requiring special dietary modifications (controlled type II diabetes mellitus was allowed)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Comprehensive Cancer Center/ We
Columbus, Ohio, 43210
About this study
Prostate Biomarkers in Men Consuming Tomato Products
Read the detailed description
Participants completed a minimum week-long washout period without consumption of tomato products prior to randomization to one of four dietary interventions. Men were randomized to one of the following dietary interventions: a controlled low lycopene diet (≤ 5 mg/d from foods), daily Prego® spaghetti sauce, daily V8® vegetable juice, or daily Campbell's® Tomato Soup. Each of the tomato products provided between 25 and 35 mg lycopene per day. In order to provide this dietary intervention in typical serving sizes in the context of a usual diet but devoid of other tomato sources, participants kept daily logs documenting compliance with the intervention product and a tomato-restricted diet from enrollment to the day of surgery (~3 weeks). Study participants were asked to complete an abbreviated dietary history questionnaire (to establish typical consumption patterns of various tomato products) and two separate 3-day diet food records, once during the washout and once during the intervention period. Blood and 24-hour urine samples were obtained at two time points, after the one-week washout phase and at the end of the dietary intervention period. Fresh prostate samples were obtained at time of surgery.
- Conditions
- Prostate Cancer
- Being tested
- Commercially-available tomato food product
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially-available tomato food productOther
Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Control | No intervention | Men in this group consumed a tomato free diet for the duration of the study (less than or equal to 5 mg lycopene/day) and, thus, did not consume a tomato intervention product. |
| Arm II: Juice | Experimental | Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day). Receives: Other: Commercially-available tomato food product |
| Arm III: Soup | Experimental | Commercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day). Receives: Other: Commercially-available tomato food product |
| Arm IV: Sauce | Experimental | Commercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day). Receives: Other: Commercially-available tomato food product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure carotenoids, including lycopene and its isomers, in blood (umol/L) and prostate tissue (nmol/g) of men after three weeks of consuming V8 vegetable juice, condensed tomato soup or tomato sauce.
Measured: Day 0 and End of Study (an average of 23 days)
Secondary outcomes (2)
Measure histobiomarkers in the prostate related to aggressive disease including Gleason Grade (number 1 - 10), tumor volume (weight) , and vascular endothelial growth factor expression (ng/mL)
Measure histobiomarkers in the prostate related to aggressive disease including Gleason Grade, tumor volume, and vascular endothelial growth factor expression
Measured: Day 0 and End of Study (an average of 23 days)
Measure biomarkers related to prostate cancer in controls and men consuming tomato food products prior to surgery. These biomarkers include plasma insulin like growth factor (ng/mL) and plasma prostate specific antigen (ng/mL)
Measure biomarkers related to prostate cancer in controls and men consuming tomato food products prior to surgery. These biomarkers include plasma insulin like growth factor (ng/mL) and plasma prostate specific antigen (ng/mL)
Measured: Day 0 and End of study (an average of 23 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startMay 2002
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Schwartz, Steven, PhD
- Responsible party
- Principal investigator, Steven Clinton, Ohio State University Comprehensive Cancer Center
- Investigators
- Steven Clinton, MD, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292524
- Sponsor's protocol ID
- OSU-0137
- Status last verified
- Nov 2014
- First submitted
- 31 Oct 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Biomarkers in Men Consuming Tomato Products
- ClinicalTrials.gov ID
- NCT02292524
- Acronym / sponsor ID
- OSU-0137
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Schwartz, Steven, PhD
- Study start
- May 2002
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate Biomarkers in Men Consuming Tomato Products
Detailed description
Participants completed a minimum week-long washout period without consumption of tomato products prior to randomization to one of four dietary interventions. Men were randomized to one of the following dietary interventions: a controlled low lycopene diet (≤ 5 mg/d from foods), daily Prego® spaghetti sauce, daily V8® vegetable juice, or daily Campbell's® Tomato Soup. Each of the tomato products provided between 25 and 35 mg lycopene per day. In order to provide this dietary intervention in typical serving sizes in the context of a usual diet but devoid of other tomato sources, participants kept daily logs documenting compliance with the intervention product and a tomato-restricted diet from enrollment to the day of surgery (~3 weeks). Study participants were asked to complete an abbreviated dietary history questionnaire (to establish typical consumption patterns of various tomato products) and two separate 3-day diet food records, once during the washout and once during the intervention period. Blood and 24-hour urine samples were obtained at two time points, after the one-week washout phase and at the end of the dietary intervention period. Fresh prostate samples were obtained at time of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I: Control | No intervention | –Men in this group consumed a tomato free diet for the duration of the study (less than or equal to 5 mg lycopene/day) and, thus, did not consume a tomato intervention product. |
| Arm II: Juice | Experimental | Other: Commercially-available tomato food productCommercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day). |
| Arm III: Soup | Experimental | Other: Commercially-available tomato food productCommercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day). |
| Arm IV: Sauce | Experimental | Other: Commercially-available tomato food productCommercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have biopsy-proven, clinically localized adenocarcinoma of the prostate based on standard presurgical staging studies
- Have chosen to undergo a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
- Have kidney and liver enzymes, CBC, and PT/PTT/INR within normal limits
- Agree to sign consent form prior to enrollment in the study
- Are currently taking lycopene or "alternative" dietary supplements
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercially-available tomato food productEach of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day. | Other | Arm II: Juice, Arm III: Soup, Arm IV: Sauce |
Primary outcome
Measure carotenoids, including lycopene and its isomers, in blood (umol/L) and prostate tissue (nmol/g) of men after three weeks of consuming V8 vegetable juice, condensed tomato soup or tomato sauce.
Time frame: Day 0 and End of Study (an average of 23 days)
2 secondary outcomes
Measure histobiomarkers in the prostate related to aggressive disease including Gleason Grade (number 1 - 10), tumor volume (weight) , and vascular endothelial growth factor expression (ng/mL)
Time frame: Day 0 and End of Study (an average of 23 days)
Measure biomarkers related to prostate cancer in controls and men consuming tomato food products prior to surgery. These biomarkers include plasma insulin like growth factor (ng/mL) and plasma prostate specific antigen (ng/mL)
Time frame: Day 0 and End of study (an average of 23 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Clinton, MD principal investigator
The Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercially-available tomato food product in people with Prostate Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site 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 7 inclusion and 0 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 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Measure carotenoids, including lycopene and its isomers, in blood (umol/L) and prostate tissue (nmol/g) of men after three weeks of consuming V8 vegetable juice, condensed tomato soup or tomato sauce. (time frame: Day 0 and End of Study (an average of 23 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2014.