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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00342992
First received: June 19, 2006
Last updated: October 15, 2014
Last verified: September 2014
  Purpose

The Alpha-Tocopherol Beta-Carotene Cancer Prevention (ATBC) Study was a large randomized, double-blind, placebo-controlled, 2x2 factorial design, primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplements on cancer incidence and mortality conducted in Finland as a collaboration between the Public Health Institute (KTL) of Finland and the U.S. National Cancer Institute. The intervention period ended in 1993, and the research project was continued as a passive follow-up of participants during the post-intervention period to monitor potential intervention effects on cancers, as well as other morbidity and mortality endpoints. The cohort follow-up serves as a basis for cancer epidemiological research of a wide range of cancer risk factors, biomarkers, and genetic predisposition based on data and biologic samples collected during the study. This research is aimed at testing hypotheses relevant to cancer prevention, etiology, and early detection, and the study material provide an invaluable resource for the study of dietary, biochemical and molecular hypotheses. The analyses are made particularly informative in that nearly 20 years of follow-up are available for study.


Condition
Stroke
Diabetes Mellitus
Heart Disease
Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Alpha-Tocopherol, Beta-Carotene Lung Cancer Prevention Study (ATBC Study) Population

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Cancer [ Time Frame: Annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Causes of Mortality [ Time Frame: Annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 29133
Study Start Date: August 1985
Detailed Description:

The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, (SqrRoot) -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), (SqrRoot) -carotene as all-trans-(SqrRoot) -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.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342992

Locations
Finland
National Public Health Institute
Helsinki, Finland
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Investigators
Principal Investigator: Demetrius A Albanes, M.D. National Cancer Institute (NCI)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00342992     History of Changes
Other Study ID Numbers: 999995012, OH95-C-N012
Study First Received: June 19, 2006
Last Updated: October 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Vitamin E
Micronutrients
Genetics
Smoking
Biomarkers

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Tocopherols
Alpha-Tocopherol
Vitamin E
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on October 19, 2014