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

• Sponsor: University of Medicine and Dentistry of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT00895115
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 65
• Location: 1
• Arms: 3
• Duration (Months): 37
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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

• Study Type: Interventional
• 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: Apr 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

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

Primary Outcome Measures

1. Effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E2 [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) [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 [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Medicine and Dentistry of New Jersey
• ClinicalTrials.gov Identifier: NCT00895115
• Other Study ID Numbers: 120802; P30CA072720; CDR0000639070
• First Posted: May 8, 2009
• Last Update Posted: Jun 14, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by University of Medicine and Dentistry of New Jersey: prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Vitamin E

Study Results

No Results Posted as of Jun 14, 2012