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

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: 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:

MedlinePlus related topics: Vitamin E

Drug Information available for: alpha-Tocopherol Tocopherol Selenomethionine alpha-Tocopherol succinate Tocopherol acetate DL-alpha-Tocopherol

U.S. FDA Resources

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


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

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

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):

Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.


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 )
Study First Received:	June 26, 2008
Results First Received:	February 15, 2017
Last Updated:	May 23, 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

ClinicalTrials.gov processed this record on July 17, 2017

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