Carotene and Retinol Efficacy Trial

NCT ID: NCT00712647

Last Updated: 2012-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1985-05-31
• Study Completion Date: 2005-06-30

Brief Summary

The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind, placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination of 30 mg of beta-carotene and 25,000 IU of retinyl palmitate in 18,314 persons at high risk for lung cancer. CARET began in 1985, and the intervention was halted in January 1996, 21 months ahead of schedule, with the twin conclusions for definitive evidence of no benefit and substantial evidence of a harmful effect of the intervention on both lung cancer incidence and total mortality. CARET continued to follow and collect endpoints on their participants through 2005. During the active intervention phase of CARET, serum, plasma, whole blood, and lung tissue specimens were collected on participants. These biospecimens make up the CARET Biorepository.

The CARET Biorepository is a valuable resource for population-based studies of the major human cancers. During CARET's twenty years of follow-up (1985-2005), we have received reports of 1,445 participants with lung cancer, 901 with prostate cancer, 433 with breast cancer, 334 with bladder cancer, 332 with colon cancer, and 1,429 with other cancers. CARET is one of the few trials that has prospectively collected serum, plasma, whole blood, blood spots (for DNA), and lung cancer tumor specimens, as well as smoking history and serial food frequency questionnaires (in some individuals for up to 12 years) in populations at high risk for lung cancer. This wealth of information in over 18,000 individuals makes the CARET Biorepository a special resource for cancer researchers.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Asbestos-exposed participants and heavy smokers

Group Type: ACTIVE_COMPARATOR

Beta Carotene and Retinol

Intervention Type: DRUG

Pilot participants (ppts):

Asbestos-Exposed--15 mg/day beta-carotene + 25,000 IU/day retinol Heavy Smokers--30 mg/day beta-carotene + 25,000 IU/day retinol

Vanguard & Efficacy ppts:

Asbestos-exposed AND heavy smokers--30 mg/day beta-carotene + 25,000 IU/day retinol

2

Asbestos-exposed participants and heavy smokers

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Two placebos, one each/day

Interventions

Beta Carotene and Retinol

Pilot participants (ppts):

Asbestos-Exposed--15 mg/day beta-carotene + 25,000 IU/day retinol Heavy Smokers--30 mg/day beta-carotene + 25,000 IU/day retinol

Vanguard & Efficacy ppts:

Asbestos-exposed AND heavy smokers--30 mg/day beta-carotene + 25,000 IU/day retinol

Intervention Type: DRUG

Placebo

Two placebos, one each/day

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Asbestos-exposed men who were:

• current smokers or quit within 15 years prior to enrollment
• had first exposure to asbestos on the job at least 15 years prior to enrollment
• had chest X-ray positive for changes compatible with asbestos exposure according to ILO criteria; or had been employed in a protocol-defined high-risk trade for at least 5 years, at least 10 years prior to enrollment.
• Heavy Smokers, men and women:

• cigarette smoking history of 20+ pack-years
• either current smokers or had quit within previous 6 years

Exclusion Criteria

• Pre-menopausal women
• History or cirrhosis or hepatitis within 12 months prior to enrollment
• Taking > 5500 IU daily vitamin A supplement
• Taking any beta-carotene supplement
• History of cancer within 5 years prior to enrollment
• SGOT > than 2.5X upper limit of normal, or alkaline phosphatase > 1.5X upper limit of normal
• taking less than 50% of study vitamins during the enrollment period between the First and Second Visits.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Fred Hutchinson Cancer Research Center

Principal Investigators

Gary E Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Other Identifiers

U01CA063673

Identifier Type: NIH

Identifier Source: secondary_id

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4239A

Identifier Type: OTHER

Identifier Source: secondary_id

FHCRC IR-4239A

Identifier Type: -

Identifier Source: org_study_id