Selenium for Prevention of Adenomatous Colorectal Polyps
Recruitment status was Recruiting
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.
Adenomatous Colorectal Polyps
Dietary Supplement: selenium
|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:||Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence|
- Recurrence of colorectal adenomatous polyps in relation to histologic type, degree of dysplasia, number, size, and location. [ Time Frame: 3 to 5 years after baseline colonoscopy ] [ Designated as safety issue: No ]Surveillance colonoscopy is recommended 3 to 5 years after removal of colorectal adenoma(s). Participants will remain on the study intervention until their surveillance colonoscopy and recurrence will be assessed per measurements above. Surveillance colonoscopy is determined by participants GI physician.
- Tolerance and adequate adherence to long-term selenium treatment as measured by adverse events, serious adverse events, every 3-4 months during treatment, and laboratory values at the beginning of the study, 6 months and annually thereafter. [ Time Frame: Monitoried for 3 to 5 years after baseline colonoscopy ] [ Designated as safety issue: Yes ]
Safety information is gathered at each study visit while participant remain on the study intervention until their surveillance colonoscopy.
Safety Issue?: (FDAAA) Yes
- To investigate effect modification of the selenium intervention by baseline blood selenium level, by low-dose aspirin (81 mg/day), by selenoprotein genetic marker polymorphisms (GPx-1, GPx-2 and SEP15). [ Time Frame: 3 to 5 years after baseline colonoscopy ] [ Designated as safety issue: No ]
- To investigate effect modification of low-dose aspirin (81 mg/day) by ornithine decarboxylase promoter genotype and effect modification of low-dose aspirin and its toxicity by slow-metabolizer genotypes of the cytochrome p450 2C9 and UGT1A6 loci. [ Time Frame: 3 to 5 years after baseline colonoscopy ] [ Designated as safety issue: No ]
|Study Start Date:||January 2001|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral selenium once daily.
Dietary Supplement: selenium
Tablet taken orally, once daily, 200 mcg, for 3-5 years depending on surveillance colonoscopy recommendation.
Other Name: SelenoExcell
Placebo Comparator: Arm II
Patients receive oral placebo once daily.
Tablet taken orally, once daily, for 3-5 years depending on surveillance colonoscopy recommendation.
- Compare the effects of selenium vs placebo on the recurrence of adenomatous colorectal polyps, in terms of histologic type, degree of dysplasia, number, size, and location, in patients with adenomatous colorectal polyps.
- Compare the type, incidence, and outcome of side effects in patients treated with these regimens.
- Determine patient adherence to long-term treatment with these regimens.
- Determine the effects of regimen modification by baseline blood selenium level, low-dose aspirin, selenoprotein genetic marker polymorphisms (e.g., GPx-1, GPx-2, and SEP15)
- Determine the effects of low-dose aspirin (81 mg/day) modification by ornithine decarboxylase promoter genotype, and toxicity by slow-metabolizer genotypes of the cytochrome p450 2C9 and UT1A6 loci in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to use of low-dose (≤ 81 mg/day) aspirin (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral selenium once daily.
- Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for up to 5 years* in the absence of disease progression or unacceptable toxicity.
Patients undergo follow-up colonoscopy approximately 5 years* after baseline colonoscopy.
NOTE: Some patients will continue participation for up to 7 and a half years
PROJECTED ACCRUAL: A total of 1,600 patients with an adenoma will be randomized to this study, followed by a second group of randomization of 200 patients with at least one advanced adenoma (at baseline) for a substudy. Total planned randomizations = 1,800 participants.
|Contact: Liane Fales, RNemail@example.com|
|United States, Arizona|
|Veterans Affairs Medical Center - Phoenix||Recruiting|
|Phoenix, Arizona, United States, 85012|
|Contact: Liane Fales, RN 602-264-4461|
|Principal Investigator: Michelle Young, MD|
|Mayo Clinic Scottsdale||Recruiting|
|Scottsdale, Arizona, United States, 85259-5499|
|Contact: Narcelle Jean-Louis 480-301-4714|
|Principal Investigator: Russell Heigh, MD|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea||Recruiting|
|Scottsdale, Arizona, United States, 85258-4512|
|Contact: Liane Fales, RN 602-264-4461 firstname.lastname@example.org|
|Arizona Cancer Center - Tucson Clinic||Recruiting|
|Tucson, Arizona, United States, 85724-5024|
|Contact: Amy Carrier, RN 520-318-7113 email@example.com|
|Contact: Kelly Kaltenhauser, RN 520-318-7113 firstname.lastname@example.org|
|Principal Investigator: M. Peter Lance, MD|
|United States, Colorado|
|University of Colorado Cancer Center at UC Health Sciences Center||Recruiting|
|Denver, Colorado, United States, 80220|
|Contact: Theresa Dunn 888-336-8262 ext 3438 email@example.com|
|Principal Investigator: Dennis Ahnen, MD|
|United States, New York|
|Endoscopy Center of Western New York||Recruiting|
|Williamsville, New York, United States, 14221|
|Contact: Pat Graham, RN 706-332-2203 firstname.lastname@example.org|
|Principal Investigator: David Fay, MD|
|United States, Texas|
|Baylor University Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Millie Arnold, RN 214-820-2691 MildredA@BaylorHealth.edu|
|Principal Investigator: Richard Boland, MD|
|Principal Investigator:||M. Peter Lance, MD||University of Arizona|