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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 is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00706121
First received: June 26, 2008
Last updated: January 13, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 and colorectal cancer (CRC) incidence [ Time Frame: Occurence of a colorectal procedure in which CRA or CRC could be evaluated is collected every 6 months ] [ Designated as safety issue: No ]
  • Effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA [ Time Frame: Occurence of a colorectal procedure in which CRA or CRC could be evaluated is collected every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of vitamin E on CRA occurrence and CRC incidence [ Time Frame: Occurence of a colorectal procedure in which CRA or CRC could be evaluated is collected every 6 months ] [ Designated as safety issue: No ]
  • Effect modification of selenium and vitamin E by aspirin on CRA occurrence [ Time Frame: Occurence of a colorectal procedure in which CRA or CRC could be evaluated and aspirin use is collected every 6 months ] [ Designated as safety issue: No ]
  • Effect modification of selenium and vitamin E by body mass index [ Time Frame: Occurence of a colorectal procedure in which CRA or CRC could be evaluated is collected every 6 months. BMI is collected annually. ] [ Designated as safety issue: No ]

Estimated Enrollment: 8000
Study Start Date: June 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (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

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
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, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00706121     History of Changes
Other Study ID Numbers: CDR0000593329, S0000D, U10CA037429
Study First Received: June 26, 2008
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 27, 2014