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

University of Medicine and Dentistry of New Jersey

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Dietary Supplement: vitamin E; Procedure: sham intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00895115

P30CA072720 (U.S. NIH Grant/Contract)

120802

CDR0000639070 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Arm I

Sham Comparator group

Description:

Patients receive no supplementation.

Treatment:

Procedure: sham intervention

Arm II

Experimental group

Description:

Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.

Treatment:

Dietary Supplement: vitamin E

Arm III

Experimental group

Description:

Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.

Treatment:

Dietary Supplement: vitamin E