Selenium for Prevention of Adenomatous Colorectal Polyps
- Conditions
- Precancerous ConditionColorectal CancerAdenomatous Colorectal Polyps
- Interventions
- Registration Number
- NCT00078897
- Lead Sponsor
- University of Arizona
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1621
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Selenium Participants receive oral placebo once daily. Selenium Selenium Participants receive oral selenium 200 mcg once daily.
- Primary Outcome Measures
Name Time Method Number of Recurrent Adenomas at Surveillance Colonoscopy 3 to 5 years after baseline colonoscopy Detection of metachronous colorectal adenomas during follow-up, by treatment, in the original cohort. 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. Surveillance colonoscopy is determined by participants' GI physician.
Median Selenium Blood Levels at One Year. One year Adequate adherence to long-term selenium treatment as measured by blood selenium levels (ng/mL) at one year.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Endoscopy Center of Western New York
🇺🇸Williamsville, New York, United States
Baylor University Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Veterans Affairs Medical Center - Phoenix
🇺🇸Phoenix, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
🇺🇸Scottsdale, Arizona, United States
Arizona Cancer Center - Tucson Clinic
🇺🇸Tucson, Arizona, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Denver, Colorado, United States