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

Colorectal Cancer Clinical Trial

— ACP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706121
• Other study ID #: CDR0000593329
• Secondary ID: S0000DU10CA03742
• Status: Completed
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: January 2018

Study information

• Verified date: December 2019
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8094
• Est. completion date: January 2018
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Precancerous Condition
• Precancerous Conditions

Intervention

Drug:
• Vitamin E
400 IU daily by mouth for 7 - 12 years
• Selenium
200 mcg daily for 7 - 12 years
• Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
• selenium placebo
1 pill by mouth daily for 7 - 12 years

Locations

Country	Name	City	State
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo		From 1 year post randomization through study completion
Other	Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo		From 1 year post randomization through study completion
Other	Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo		From 1 year post randomization through study completion
Other	Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo		From 1 year post randomization through study completion
Primary	Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo		From 1 year post randomization through study completion
Primary	Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo	Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia	From 1 year post randomization through study completion
Primary	Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence		From 1 year post randomization through study completion
Primary	Effect of Selenium on Occurrences of Multiple (>2) Adenomas		From 1 year post randomization through study completion
Secondary	Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo		From 1 year post randomization through study completion