Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study

Stroke Clinical Trial

Official title:

Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC Study) Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00342992
• Other study ID #: 999995012
• Secondary ID: OH95-C-N012
• Status: Completed
• Start date: March 3, 1995
• Est. completion date: September 4, 2020

Study information

• Verified date: September 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The project is a passive follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort. Originally, this was a large, randomized, double-blind, placebo-controlled, 2x2 factorial primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplementation on cancer incidence and mortality. The study was conducted in Finland as a collaboration between the U.S. National Cancer Institute (NCI) and the National Public Health Institute of Finland. NCI has maintained passive surveillance of the cohort through Finnish national registries, including the cancer registry.

The primary purpose of the ATBC cohort follow-up is to use the existing risk factor data and biological specimens (i.e., serum, whole blood, DNA, red blood cells, and toenails) to test hypotheses relevant to cancer etiology, survival, early detection, and prevention. These data and biospecimens continue to provide an invaluable resource for the study of biochemical, nutritional, genetic, and molecular hypotheses. These analyses are made all the more informative and powerful by the addition of cases identified annually during the follow-up period, and the research benefits from a longer pre-diagnosis period (now over 30 years).

Description:

The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, beta-carotene, or both would reduce the incidence of lung or other cancers among male smokers. Between 1985 and 1988, 29,133 men ages 50 to 69 years, who smoked at least five cigarettes per day, were recruited from southwestern Finland. Participants were randomly assigned to receive either a-tocopherol as dl-a-tocopheryl acetate (50 mg/day), beta-carotene as all-trans-beta-carotene (20 mg/day), both supplements, or placebo capsules for 5-8 years (median 6.1 years) through April 30, 1993. Post-intervention follow-up has continued through the Finnish Cancer Registry and other national registries, and epidemiological analyses continue to be conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29133
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 69 Years

Eligibility

• INCLUSION CRITERIA:

Current smokers (five or more cigarettes per day at study entry) from Southwestern Finland.

EXCLUSION CRITERIA:

• Females

• Proven malignancy (except nonmelanoma skin cancer or cancer in situ)

• Severe angina pectoris

• Chronic renal insufficiency

• Cirrhosis of the liver

• Chronic alcoholism

• Anticoagulant therapy

• Use of supplements containing vitamin E greater than 20 mg/day, or vitaming A greater than 20,000 IU/day, or beta-carotene greater than 6 mg/day

Related Conditions & MeSH terms

• Cancer
• Diabetes Mellitus
• Heart Disease
• Heart Diseases
• Stroke

Locations

Country	Name	City	State
Finland	National Institute of Health and Welfare, Helsinki, Finland	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Finnish Institute for Health and Welfare

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994 Apr 14;330(15):1029-35. — View Citation

Heinonen OP, Albanes D, Virtamo J, Taylor PR, Huttunen JK, Hartman AM, Haapakoski J, Malila N, Rautalahti M, Ripatti S, Mäenpää H, Teerenhovi L, Koss L, Virolainen M, Edwards BK. Prostate cancer and supplementation with alpha-tocopherol and beta-carotene: incidence and mortality in a controlled trial. J Natl Cancer Inst. 1998 Mar 18;90(6):440-6. — View Citation

The alpha-tocopherol, beta-carotene lung cancer prevention study: design, methods, participant characteristics, and compliance. The ATBC Cancer Prevention Study Group. Ann Epidemiol. 1994 Jan;4(1):1-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer	Annual linkage with Finnish Cancer Registry	Annually
Secondary	Causes of mortality		Anually