Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Chemoprevention is the use of certain drugs or nutritional supplements to keep cancer from forming, growing, or coming back. The use of vitamin E, ascorbic acid, beta carotene, and/or multivitamins may keep cancer or other diseases, such as cardiovascular disease, from forming.

PURPOSE: This randomized clinical trial is studying vitamin E, ascorbic acid, beta carotene, and/or multivitamins to see how well they work compared to placebos in preventing prostate cancer, other cancers, or cardiovascular disease in healthy older male doctors. NOTE: Beta carotene was no longer given as of 3/8/2003.

Further Study Information

OBJECTIVES:

Primary

• Determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians.

• Determine whether daily ascorbic acid and/or a multivitamin reduces the risk of total cancer in these participants.

• Determine whether vitamin E every other day, ascorbic acid daily, or a multivitamin daily reduces the risk of important vascular events in these participants (beta carotene portion of study discontinued as of 3/8/2003).

Secondary

• Determine whether vitamin E and/or multivitamins reduce the risk of developing total cancer, colon cancer, and colon polyps in these participants.

• Determine whether vitamin E, ascorbic acid, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.

• Determine whether vitamin E, ascorbic acid, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.

• Determine whether vitamin E, ascorbic acid, or multivitamins reduce the risk of early cognitive decline in men aged 65 and over.

OUTLINE: This is a randomized, double-blind, placebo-controlled study.

• Pre-randomization run-in phase: Participants who did not participate in the Physicians' Health Study I (PHS I) receive vitamin E placebo once every other day, ascorbic acid placebo once daily, multivitamin placebo once daily, and beta carotene placebo once every other day for 12 weeks. Participants demonstrating compliance with pill taking proceed, along with participants who participated in PHS I, to the randomized phase. (Beta carotene portion of study discontinued as of 3/8/2003.)

• Randomized phase: Participants are randomized to receive all active supplements, all placebos, or any combination comprising oral vitamin E or placebo once every other day, oral ascorbic acid or placebo once daily, oral multivitamin or placebo once daily, and/or oral beta carotene or placebo once every other day for 4 years. (Beta carotene portion of study discontinued as of 3/8/2003.)

PROJECTED ACCRUAL: A total of 14,661 participants were accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Healthy male physician practicing in the United States

• Prior participation in the Physicians' Health Study I allowed

PATIENT CHARACTERISTICS:

Age

• 50 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No history of liver disease

Renal

• Not specified

Other

• No history of other serious illness that would preclude study participation

• No history of significant adverse events (e.g., rash or allergic reaction) attributed to study agents

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No other concurrent vitamin and/or multivitamin supplementation

• No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)

Trial Contact Information

Trial Lead Organizations/Sponsors

Dana-Farber/Brigham and Women's Cancer Center

J. Michael Gaziano

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00270647
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top