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| Sponsor: | University of Arizona |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Arizona |
| ClinicalTrials.gov Identifier: | NCT00078897 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Adenomatous Colorectal Polyps Precancerous Condition |
Dietary Supplement: selenium Other: placebo |
Phase III |
| 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: | Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence |
Safety information is gathered at each study visit while participant remain on the study intervention until their surveillance colonoscopy.
Safety Issue?: (FDAAA) Yes
| Estimated Enrollment: | 1800 |
| Study Start Date: | January 2001 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: placebo
Tablet taken orally, once daily, for 3-5 years depending on surveillance colonoscopy recommendation.
|
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Meets the following criteria by colonoscopy (performed within the past 6 months):
No prior diagnosis of any of the following:
Hereditary non-polyposis colon cancer (HNPCC), defined as:
Colorectal cancer diagnosis in at least 1 family member who is less than 50 years of age
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No poorly controlled diabetes mellitus despite medication, defined as:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Contact: Liane Fales, RN | 602-264-4461 | lfales@email.arizona.edu |
| 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 lfales@email.arizona.edu | |
| Arizona Cancer Center - Tucson Clinic | Recruiting |
| Tucson, Arizona, United States, 85724-5024 | |
| Contact: Amy Carrier, RN 520-318-7113 acarrier@azcc.arizona.edu | |
| Contact: Kelly Kaltenhauser, RN 520-318-7113 kkaltenhauser@azcc.arizona.edu | |
| 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 theresa.dunn@ucdenver.edu | |
| 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 pgraham@ecwny.com | |
| 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 |
More Information
| Responsible Party: | M. Peter Lance, Arizona Cancer Center at University of Arizona Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00078897 History of Changes |
| Other Study ID Numbers: | CDR0000353185, P30CA023074, UARIZ-00-0430-01, UARIZ-HSC-00142, P01CA041108 |
| Study First Received: | March 8, 2004 |
| Last Updated: | October 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
colon cancer rectal cancer colorectal cancer adenomatous polyp |
|
Colorectal Neoplasms Disease Polyps Precancerous Conditions Adenomatous Polyps Colonic Polyps Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Pathologic Processes Pathological Conditions, Anatomical Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Intestinal Polyps Selenium Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action |