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Carotene and Retinol Efficacy Trial (CARET)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00712647
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Dietary Supplement: Beta Carotene and Retinol
Other: Placebo
Phase IV

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Vitamin A Retinol Carotenoids beta Carotene
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Caret and Retinol Efficacy Trial: The Caret Coordinating Center

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Lung Cancer Incidence [ Time Frame: bi-annual ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Other cancers [ Time Frame: bi-annual ] [ Designated as safety issue: Yes ]

Enrollment: 18314
Study Start Date: May 1985
Estimated Study Completion Date: December 2018
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Asbestos-exposed participants and heavy smokers
Dietary Supplement: 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

2: Placebo Comparator
Asbestos-exposed participants and heavy smokers
Other: Placebo
Two placebos, one each/day

  Eligibility

Ages Eligible for Study:   45 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712647

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Gary E Goodman, MD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Fred Hutchinson Cancer Research Center ( Gary Goodman, MD )
Study ID Numbers: FHRCR IR-4239A, UO1 CA63673
Study First Received: July 8, 2008
Last Updated: July 9, 2008
ClinicalTrials.gov Identifier: NCT00712647  
Health Authority: United States: Food and Drug Administration;   United States: Fred Hutchinson Cancer Research Center IRB

Study placed in the following topic categories:
Thoracic Neoplasms
Beta Carotene
Retinol palmitate
Respiratory Tract Diseases
Lung Neoplasms
Vitamin A
Lung Diseases
Carotenoids

Additional relevant MeSH terms:
Anticarcinogenic Agents
Respiratory Tract Neoplasms
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009