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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Southwest Oncology Group

Current Primary Outcome:

  • Effect of Selenium on Colorectal Adenoma (CRA) Occurrence [ Time Frame: Occurence of a colorectal procedure in which CRA could be evaluated is collected every 6 months ]
  • Effect of Selenium on Advanced Neoplasia [ Time Frame: Occurence of a colorectal procedure in which CRA or CRC could be evaluated is collected every 6 months ]
    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: Occurence of a colorectal procedure in which CRC could be evaluated is collected every 6 months ]
  • Effect of Selenium on Occurrences of Multiple (>2) Adenomas [ Time Frame: Occurence of a colorectal procedure in which CRA could be evaluated is collected every 6 months ]


Original Primary Outcome:

  • Effect of selenium on colorectal adenoma (CRA) occurrence and colorectal cancer (CRC) incidence
  • Effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA


Current Secondary Outcome: Effect of Vitamin E on CRA Occurrence [ Time Frame: Occurence of a colorectal procedure in which CRA could be evaluated is collected every 6 months ]

Original Secondary Outcome:

  • Effect of vitamin E on CRA occurrence and CRC incidence
  • Effect modification of selenium and vitamin E by aspirin on CRA occurrence
  • Effect modification of selenium and vitamin E by body mass index


Information By: Southwest Oncology Group

Dates:
Date Received: June 26, 2008
Date Started: June 2008
Date Completion:
Last Updated: February 15, 2017
Last Verified: February 2017