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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.
First Received: December 27, 2005   Last Updated: February 6, 2009   History of Changes
Sponsor: Dana-Farber/Brigham and Women's Cancer Center
Collaborator: 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
 Dietary Supplement: ascorbic acid
Dietary Supplement: beta carotene
Dietary Supplement: multivitamin
Dietary Supplement: vitamin E

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Dietary Supplements Diets Prostate Cancer
Drug Information available for: Carotenoids Ascorbic acid alpha-Tocopheryl acetate alpha-Tocopherol Vitamin E Tocopherols Tocotrienol beta Carotene
U.S. FDA Resources

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

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

Publications:
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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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: February 6, 2009
ClinicalTrials.gov Identifier: NCT00270647     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
prostate cancer
colon cancer
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Urogenital Neoplasms
Rectal Diseases
Tocopherols
Neoplasms by Site
Vitamins
Tocotrienols
Cardiovascular Diseases
 Micronutrients
Tocopherol acetate
Digestive System Neoplasms
Growth Substances
Intestinal Diseases
Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Intestinal Neoplasms
Alpha-Tocopherol
Neoplasms
Vitamin E
Digestive System Diseases
Gastrointestinal Neoplasms
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 05, 2009



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