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


N/A
50 Years
69 Years
Open (Enrolling)
Male
Lung Cancer, Prostatic Neoplasms, Prostate Cancer, Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Incidence of and mortality from lung cancer during intervention (ended April 1993) and post-intervention.

Principal Investigator

Demetrius A Albanes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999995012

NCT ID:

NCT00342992

Start Date:

August 1985

Completion Date:

Related Keywords:

  • Lung Cancer
  • Prostatic Neoplasms
  • Prostate Cancer
  • Pancreatic Cancer
  • Alpha-tocopherol (vitamin E)
  • Beta-carotene
  • Lung Neoplasms
  • Cardiovascular Disease
  • Diabetes
  • Randomized controlled trials
  • Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms

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