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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Dietary Supplement: vitamin E; Procedure: sham intervention	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	65 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Prostate
Study Start Date :	April 2009
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Sham Comparator: Arm I; Patients receive no supplementation.	Procedure: sham intervention; No supplementation
Experimental: Arm II; Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.	Dietary Supplement: vitamin E; Given once daily
Experimental: Arm III; Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.	Dietary Supplement: vitamin E; Given once daily

Outcome Measures

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Primary Outcome Measures :

1. Effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E2 [ Time Frame: 4 years ]
2. 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) [ Time Frame: 4 years ]
3. Levels of α-, γ-, and δ-tocopherols in prostate tissues and cell proliferation, apoptosis, cyclooxygenase-2, 8-OHdG, and 3-nitropyrosine levels as assessed by IHC [ Time Frame: 4 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

University of Medicine and Dentistry of New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Susan Goodin, PharmD, FCCP, BCOP	Rutgers Cancer Institute of New Jersey

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier:	NCT00895115 History of Changes
Other Study ID Numbers:	120802; P30CA072720 ( U.S. NIH Grant/Contract ); CDR0000639070 ( Other Identifier: NIH )
First Posted:	May 8, 2009
Last Update Posted:	June 14, 2012
Last Verified:	June 2012

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):

prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Vitamins; Vitamin E	Tocopherols; Tocotrienols; alpha-Tocopherol; Micronutrients; Growth Substances; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents