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S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 (ACP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00706121
First Posted: June 27, 2008
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
  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 Condition Drug: Vitamin E Drug: Selenium Drug: Vitamin E placebo Drug: selenium placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo [ Time Frame: From 1 year post randomization through study completion ]
  • Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo [ Time Frame: From 1 year post randomization through study completion ]
    Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia

  • Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence [ Time Frame: From 1 year post randomization through study completion ]
  • Effect of Selenium on Occurrences of Multiple (>2) Adenomas [ Time Frame: From 1 year post randomization through study completion ]

Secondary Outcome Measures:
  • Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo [ Time Frame: From 1 year post randomization through study completion ]

Other Outcome Measures:
  • Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo [ Time Frame: From 1 year post randomization through study completion ]
  • Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo [ Time Frame: From 1 year post randomization through study completion ]
  • Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo [ Time Frame: From 1 year post randomization through study completion ]
  • Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo [ Time Frame: From 1 year post randomization through study completion ]

Enrollment: 8094
Study Start Date: June 2008
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
Drug: Vitamin E
400 IU daily by mouth for 7 - 12 years
Other Name: alpha tocopherol
Drug: selenium placebo
1 pill by mouth daily for 7 - 12 years
Other Name: placebo
Experimental: Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
Drug: Selenium
200 mcg daily for 7 - 12 years
Other Name: L-selenomethionine
Drug: Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
Other Name: placebo
Experimental: Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
Drug: Vitamin E
400 IU daily by mouth for 7 - 12 years
Other Name: alpha tocopherol
Drug: Selenium
200 mcg daily for 7 - 12 years
Other Name: L-selenomethionine
Placebo Comparator: Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Drug: Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
Other Name: placebo
Drug: selenium placebo
1 pill by mouth daily for 7 - 12 years
Other Name: placebo

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 120 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706121


Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 86724
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: M. Peter Lance, MD University of Arizona
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00706121     History of Changes
Other Study ID Numbers: CDR0000593329
S0000D ( Other Identifier: SWOG )
U10CA037429 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2008
First Posted: June 27, 2008
Results First Submitted: February 15, 2017
Results First Posted: April 4, 2017
Last Update Posted: June 20, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://swog.org/Visitors/Download/Policies/Policy43.pdf

Keywords provided by Southwest Oncology Group:
colon cancer
rectal cancer
adenomatous polyp

Additional relevant MeSH terms:
Colorectal Neoplasms
Precancerous Conditions
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Selenium
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements


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