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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895115
• Other study ID #: 120802
• Secondary ID: P30CA072720CDR00
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2009
• Last updated: June 12, 2012
• Start date: April 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Meets one of the following criteria:

• Abnormal digital rectal examination or abnormal prostate specific antigen (> 4.0 ng/mL)

• Obstructing prostate

• Biopsy-proven prostate cancer

• Scheduled to undergo prostate surgery (i.e., transurethral prostatectomy or prostatectomy)

PATIENT CHARACTERISTICS:

• No uncontrolled diabetes, uncontrolled blood pressure, chronic congestive heart failure, or history of renal insufficiency

• No personal or family history of a bleeding disorder

• No known history of problems absorbing dietary fats (e.g., Crohn's disease, cystic fibrosis)

PRIOR CONCURRENT THERAPY:

• More than 2 weeks since prior NSAIDs or corticosteroids

• No concurrent supplementation of vitamin E (a multivitamin containing = 60 IU of vitamin E is allowed)

• No concurrent colestipol or orlistat

• No concurrent warfarin or dicumarol

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• vitamin E
Given once daily

Procedure:
• sham intervention
No supplementation

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of tocopherol supplementation on plasma and urine levels of a-, ?-, and d-tocopherols, PSA, and prostaglandin E2		4 years	No
Primary	Oxidative stress and nitrosative stress as assessed by plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG)		4 years	No
Primary	Levels of a-, ?-, and d-tocopherols in prostate tissues and cell proliferation, apoptosis, cyclooxygenase-2, 8-OHdG, and 3-nitropyrosine levels as assessed by IHC		4 years	No