Carotene and Retinol Efficacy Trial

NCT00712647 | Completed Phase 4 DMC

• 3 other identifiers: FHCRC IR-4239AU01CA0636734239A
• Study Type: interventional
• Target: 18,314
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Lung Cancer Incidence

  bi-annual

Secondary Outcomes (1)

• Other cancers

  bi-annual

Study Arms (2)

1

ACTIVE COMPARATOR

Asbestos-exposed participants and heavy smokers

Drug: Beta Carotene and Retinol

2

PLACEBO COMPARATOR

Asbestos-exposed participants and heavy smokers

Other: Placebo

Interventions

Beta Carotene and Retinol 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

1

Placebo OTHER

Two placebos, one each/day

2

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms

Interventions

beta Carotene; Vitamin A

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Retinoids; Diterpenes

Study Officials

• Gary E Goodman, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 10, 2008
• Study Start: May 1, 1985
• Primary Completion: December 1, 2004
• Study Completion: June 1, 2005
• Last Updated: September 26, 2012

Record last verified: 2012-09