Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00706121

Purpose

RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment.

PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.

Condition	Intervention	Phase
Colorectal Cancer Precancerous/Nonmalignant Condition	Drug: selenium Drug: vitamin E Procedure: histopathologic examination Procedure: medical chart review	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Selenium

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effect of selenium on colorectal adenoma (CRA) occurrence and colorectal cancer (CRC) incidence [ Designated as safety issue: No ]
Effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of vitamin E on CRA occurrence and CRC incidence [ Designated as safety issue: No ]
Effect modification of selenium and vitamin E by aspirin on CRA occurrence [ Designated as safety issue: No ]
Effect modification of selenium and vitamin E by body mass index [ Designated as safety issue: No ]

Estimated Enrollment:	8000
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To assess the effect of selenium on colorectal adenoma (CRA) occurrence.
To assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA.
To assess the effect of selenium on colorectal cancer (CRC) incidence.

Secondary

To assess the effect of vitamin E on CRA occurrence.
To assess the effect of vitamin E on CRC incidence.

Tertiary

To explore the effect modification of selenium and vitamin E by aspirin on CRA occurrence.
To explore the effect modification of selenium and vitamin E by body mass index.

OUTLINE: This is a multicenter study.

Endoscopically obtained tissue samples are reviewed by study pathologists to confirm the presence (or absence) of a colorectal adenoma (CRA). If a CRA is present, the number, location, size, histology, and degree of dysplasia are documented. The CRA is also reviewed to exclude a diagnosis of colorectal cancer.

Additional data, including aspirin use, height and weight, date of birth, and other demographic and baseline characteristics, is also obtained. Participants' medical records are reviewed periodically.

Participants are followed annually.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Enrolled on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000
Screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after randomization on SELECT trial

PATIENT CHARACTERISTICS:

Willing to sign an applicable medical records release form
Willing to allow the release of tissue for central pathology review of resected polyps and endoscopic biopsies

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706121

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:

M. Peter Lance, MD

University of Arizona

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000593329, SWOG-S0000D
Study First Received:	June 26, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00706121
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

colon cancer
rectal cancer
adenomatous polyp

Study placed in the following topic categories:

Tocopherol acetate
Digestive System Neoplasms
Precancerous Conditions
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Polyps
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Alpha-Tocopherol
Rectal neoplasm
Tocopherols
Selenium
Vitamin E
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms
Adenomatous Polyps

Additional relevant MeSH terms:

Neoplasms
Antioxidants
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Vitamins
Growth Substances

Physiological Effects of Drugs
Trace Elements
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009