Prostate Biomarkers in Men Consuming Tomato Products

Prostate Cancer Clinical Trial

Official title:

Prostate Biomarkers in Men Consuming Tomato Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292524
• Other study ID #: OSU-0137
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: November 12, 2014
• Start date: May 2002
• Est. completion date: October 2004

Study information

• Verified date: November 2014
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Prostate Biomarkers in Men Consuming Tomato Products

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: To be included in this study, men must:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Other:
• Commercially-available tomato food product
Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center/ We	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Schwartz, Steven, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Day 0 and End of Study (an average of 23 days)	No
Secondary	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	Day 0 and End of Study (an average of 23 days)	No
Secondary	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)	Day 0 and End of study (an average of 23 days)	No

External Links

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