Physicians' Health Study II

Prostate Cancer Clinical Trial

— PHS II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270647
• Other study ID #: CDR0000448630
• Secondary ID: BWH-1999-P-00331
• Status: Completed
• Phase: N/A
• First received: December 27, 2005
• Last updated: February 26, 2018
• Start date: July 1997
• Est. completion date: June 2011

Study information

• Verified date: February 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer, cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how well they work compared with placebos in preventing cancer, cardiovascular disease, eye disease, and cognitive decline in male doctors aged 50 years and older.

Description:

OBJECTIVES:

Primary

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

• To determine whether daily vitamin C and/or a multivitamin reduces the risk of total cancer in these participants.

• To determine whether vitamin E every other day, vitamin C daily, or a multivitamin daily reduces the risk of major cardiovascular events in these participants.

Secondary

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

• To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.

• To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.

• To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of early cognitive decline in participants aged 65 and over.

The Physicians' Health Study II was a randomized, double-blind, placebo-controlled, factorial trial that began in 1997 and ended in 2011. It was designed to test four supplements -- (1) alternate-day vitamin E (400 international units of synthetic alpha-tocopherol) or its placebo; (2) daily vitamin C (500 mg synthetic ascorbic acid) or its placebo; (3) a daily multivitamin (Centrum Silver) or its placebo; and (4) alternate-day beta carotene (50 mg Lurotin) or its placebo -- in the prevention of cancer, cardiovascular disease, eye disease, and early cognitive decline among 14,641 male physicians aged 50 years or older. Participants were randomly assigned in a 2x2x2x2 factorial trial to receive combinations of the four active supplements or their placebos. Pills and/or packaging were provided by BASF Corporation, Pfizer (formerly Wyeth, American Home Products, and Lederle), and DSM Nutritional Products (formerly Roche Vitamins).

The beta-carotene component was discontinued on March 8, 2003; the vitamin E and vitamin C components ended as scheduled on August 31, 2007; and the multivitamin component ended on June 1, 2011.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14641
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

INCLUSION CRITERIA

1. DISEASE CHARACTERISTICS:

• Healthy male physicians practicing in the United States

• Prior participation in the Physicians' Health Study I allowed

2. PATIENT CHARACTERISTICS:

• Aged 50 years and over

• No history of serious illness that would preclude study participation

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

3. PRIOR CONCURRENT THERAPY:

• No other concurrent vitamin and/or multivitamin supplementation

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

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Disease
• Cardiovascular Diseases
• Cognitive Decline
• Cognitive Dysfunction
• Colorectal Cancer
• Colorectal Neoplasms
• Eye Disease
• Eye Diseases
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Vitamin E
400 IU synthetic alpha-tocopherol or its placebo on alternate days (provided by BASF)
• Vitamin C
500 mg synthetic ascorbic acid or its placebo daily (provided by BASF)
• Multivitamin
Centrum Silver or its placebo daily (provided by Pfizer (formerly Wyeth, American Home Products, and Lederle))
• Beta-carotene
50 mg Lurotin or placebo on alternate days (provided by BASF)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Cancer Institute (NCI)

References & Publications (6)

Christen WG, Gaziano JM, Hennekens CH. Design of Physicians' Health Study II--a randomized trial of beta-carotene, vitamins E and C, and multivitamins, in prevention of cancer, cardiovascular disease, and eye disease, and review of results of completed trials. Ann Epidemiol. 2000 Feb;10(2):125-34. Review. — View Citation

Christen WG, Glynn RJ, Sesso HD, Kurth T, MacFadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Age-related cataract in a randomized trial of vitamins E and C in men. Arch Ophthalmol. 2010 Nov;128(11):1397-405. doi: 10.1001/archophthalmol.2010.266. — View Citation

Christen WG, Glynn RJ, Sesso HD, Kurth T, Macfadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Vitamins E and C and medical record-confirmed age-related macular degeneration in a randomized trial of male physicians. Ophthalmology. 2012 Aug;119(8):1642- — View Citation

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 J — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer		Ongoing
Primary	Total cancer		Ongoing
Primary	Major cardiovascular events		Ongoing
Secondary	Cataract		Ongoing
Secondary	Age-related macular degeneration		Ongoing
Secondary	Early cognitive decline		Ongoing
Secondary	Myocardial infarction		Ongoing
Secondary	Stroke		Ongoing
Secondary	Colorectal cancer		Ongoing