Physicians' Health Study II: Vitamin E, Ascorbic Acid, Beta Carotene, and/or Multivitamins in Preventing Cancer and Cardiovascular Disease in Older Healthy Male Doctors - Tabular View

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Physicians' Health Study II: Vitamin E, Ascorbic Acid, Beta Carotene, and/or Multivitamins in Preventing Cancer and Cardiovascular Disease in Older Healthy Male Doctors

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Physicians' Health Study II: Vitamin E, Ascorbic Acid, Beta Carotene, and/or Multivitamins in Preventing Cancer and Cardiovascular Disease in Older Healthy Male Doctors

Official Title ^†

Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease

Brief 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.

Detailed Description

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Colorectal Cancer
Prostate Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^†

Drug: ascorbic acid
Drug: beta carotene
Drug: multivitamin
Drug: vitamin E

MEDLINE PMIDs

Links

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

Completion Date

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)

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00270647

Organization ID

CDR0000448630

Secondary IDs ^††

BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405

Study Sponsor ^†

Dana-Farber/Brigham and Women's Cancer Center

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

J. Michael Gaziano, MD, MPH

Dana-Farber/Brigham and Women's Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2006

First Received Date ^†

December 27, 2005

Last Updated Date

July 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.