NCT00895115

Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer

A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Prostate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vitamin E supplements may stop or delay the development of prostate cancer in patients who are at risk of prostate cancer or who have prostate cancer. It is not yet known which vitamin E regimen is more effective in preventing prostate cancer. PURPOSE: This randomized phase I trial is comparing vitamin E supplement regimens to see how well they work in preventing cancer in patients at risk of prostate cancer or who have prostate cancer.

Detailed description

OBJECTIVES: * Determine the effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E\_2 by comparing the blood and urine samples collected before and after the supplementation in patients with prostate cancer. * Test the hypothesis that the supplementation reduced oxidative and nitrosative stress by measuring plasma levels of F\_2-isoprostane, C-reactive protein, and 3-nitrotyrosine as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG). * Determine the levels of α-, γ-, and δ-tocopherols in prostate tissues and analyze immunohistochemically (IHC) for cell proliferation, apoptosis, cyclooxygenase-2, 8-OHdG, and 3-nitropyrosine levels in prostate cancer/tissue slides. OUTLINE: Patients are randomized into 1 of 3 arms. * Arm I: Patients receive no supplementation. * Arm II: Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week. * Arm III: Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks. Blood, urine, and tissue samples are collected periodically and analyzed for oxidative/nitrosative stress and other markers (i.e., F2-isoprostane, 8-OHdG, 3-nitrotyrosine, prostaglandin E2, C-reactive protein, and PSA), biomarkers in prostate tumors and nontumorous tissues (i.e., 8-OHdG, 3-nitrotyrosine, and cyclooxygenase-2) by IHC, and pharmacokinetics by high-performance liquid chromatography.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin E	Given once daily
PROCEDURE	sham intervention	No supplementation

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-05-08
• Last updated: 2012-06-14

Locations

1 site across 1 country: United States