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

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

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

MedlinePlus related topics: Cancer Colorectal Cancer Prostate Cancer

Drug Information available for: 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 of Results:

Gaziano JM, Glynn RJ, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Sesso HD, Buring JE. Vitamins E and C in the prevention of prostate and total cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2009 Jan 7;301(1):52-62. Epub 2008 Dec 9.

Publications indexed to this study:

Sesso HD, Buring JE, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Glynn RJ, Gaziano JM. Vitamins E and C in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2008 Nov 12;300(18):2123-33. Epub 2008 Nov 9.

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
Study First Received:	December 27, 2005
Last Updated:	January 15, 2009
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
Prostatic Diseases
Genital Neoplasms, Male
Gastrointestinal Diseases
Eye Diseases
Colonic Diseases
Urogenital Neoplasms
Healthy
Genital Diseases, Male
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Alpha-Tocopherol
Tocopherols
Vitamin E
Digestive System Diseases
Gastrointestinal Neoplasms
Prostatic Neoplasms
Carotenoids
Ascorbic Acid
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Antioxidants
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Growth Substances

Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009