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

Purpose

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.

Condition	Intervention
Colorectal Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific	Drug: ascorbic acid Drug: beta carotene Drug: multivitamin Drug: vitamin E

Genetics Home Reference related topics:

Benign Tumors Cancer Colorectal Cancer

MedlinePlus related topics:

Cancer Colorectal Cancer Prostate Cancer

ChemIDplus related topics:

Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Ascorbic acid Carotenoids beta Carotene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control

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

Further study details as provided by National Cancer Institute (NCI):

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270647

Sponsors and Collaborators

Dana-Farber/Brigham and Women's Cancer Center

National Cancer Institute (NCI)

Investigators


Study Chair:	J. Michael Gaziano, MD, MPH	Dana-Farber/Brigham and Women's Cancer Center

More Information

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

Publications indexed to this study:

Grodstein F, Kang JH, Glynn RJ, Cook NR, Gaziano JM. A randomized trial of beta carotene supplementation and cognitive function in men: the Physicians' Health Study II. Arch Intern Med. 2007 Nov 12;167(20):2184-90.

Study ID Numbers:	CDR0000448630, BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405
First Received:	December 27, 2005
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00270647
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

prostate cancer

colon cancer

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Beta Carotene

Tocopherol acetate

Digestive System Neoplasms

Genital Neoplasms, Male

Prostatic Diseases

Gastrointestinal Diseases

Colonic Diseases

Urogenital Neoplasms

Healthy

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Alpha-Tocopherol

Tocopherols

Vitamin E

Gastrointestinal Neoplasms

Prostatic Neoplasms

Carotenoids

Ascorbic Acid

Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms

Antioxidants

Digestive System Diseases

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Growth Substances

Vitamins

Physiological Effects of Drugs

Micronutrients

Genital Diseases, Male

Protective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008

Sponsors and Collaborators:	Dana-Farber/Brigham and Women's Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00270647