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Selenium in Treating Patients With Adenomatous Colorectal Polyps
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
First Received: March 8, 2004   Last Updated: February 6, 2009   History of Changes
Sponsor: University of Arizona
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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
Precancerous/Nonmalignant Condition
Dietary Supplement: selenium
Other: placebo
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence rate and size of colorectal polyps reduction as measured by colonoscopy after 3-5 year of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: Yes ]

Estimated Enrollment: 2050
Study Start Date: January 2001
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral selenium once daily.
Dietary Supplement: selenium
Given orally
Arm II: Placebo Comparator
Patients receive oral placebo once daily.
Other: placebo
Given orally

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 1,850 patients will be accrued for this study followed by a second accrual of 200 patients with advanced adenoma for a substudy.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal adenomatous polyps
  • Meets the following criteria by colonoscopy (performed within the past 6 months):

    • Cecum was totally visualized or reached
    • At least 90% visualization of colon surface area
    • Removed at least 1 adenomatous polyp of at least 3 mm in size during procedure
    • Removed no more than 10 adenomatous polyps of any size by endoscopy
    • All other neoplastic and non-neoplastic colon polyps must have been completely removed (except for diminutive [less than 3 mm] sessile rectal polyps)
    • For the sub-study, at least 1 advanced adenomatous polyp defined as 10 mm or greater in size and/or has villous histology and/or shows high grade dysplasia
  • No prior diagnosis of any of the following:

    • Colorectal cancer
    • Familial adenomatous polyposis
    • Ulcerative colitis
    • Crohn's disease
    • Hereditary non-polyposis colon cancer (HNPCC), defined as:

      • Histologically confirmed colorectal cancer in at least 3 relatives, 1 of whom is a first-degree relative of the other 2
      • Disease occurrence in at least 2 consecutive generations
      • Colorectal cancer diagnosis in at least 1 family member who is less than 50 years of age

        • Patients with a family history of colorectal cancer but who are not diagnosed with HNPCC are allowed
  • No more than 1 prior segmental colon resection

PATIENT CHARACTERISTICS:

Age

  • 40 to 80

Performance status

  • SWOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin > 11 g/dL
  • WBC 3,000 - 11,000/mm^3

Hepatic

  • AST and ALT < 2 times upper limit of normal
  • Bilirubin < 2.0 mg/dL

Renal

  • Creatinine < 1.9 mg/dL

Cardiovascular

  • No unstable* cardiac disease despite medication (e.g., diuretics or digitalis)
  • No uncontrolled hypertension (i.e., systolic blood pressure ≥ 170 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg) despite medication NOTE: *Unstable defined as unable to walk across the room without chest pain or shortness of breath

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception for at least 2 months before and during study treatment
  • Resident of a clinical center metropolitan area or obtaining regular health care in a clinical metropolitan area for at least 6 months out of the year
  • Must be able to swallow pills
  • No unexpected weight loss of 10% or more within the past 6 months
  • No prior rheumatoid arthritis
  • No poorly controlled diabetes mellitus despite medication, defined as:

    • Blood sugar level ≥ 200 mg/dL on more than half of the readings taken within the past month
  • No invasive malignancy within the past 5 years that required medical excision, radiotherapy, or chemotherapy except basal cell or squamous cell carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent drugs that regulate the immune system

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Prior enrollment in another adenoma prevention study allowed
  • Concurrent routine aspirin (≤ 81 mg/day) allowed
  • No regular use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • No concurrent enrollment in another research study using pharmacological cancer drugs, a cyclo-oxygenase-2 inhibitor, or selenium
  • No other concurrent selenium unless dosage is ≤ 50 µg/day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078897

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center Recruiting
Tucson, Arizona, United States, 85724-5024
Contact: Clinical Trials Office - Arizona Cancer Center at University o     520-626-9008        
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
Veterans Affairs Medical Center - Phoenix Recruiting
Phoenix, Arizona, United States, 85012
Contact: Francisco Ramirez, MD     602-264-4461        
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    
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Dennis J. Ahnen, MD     303-399-8020 x3018        
United States, Texas
Baylor University Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75246
Contact: Clinical Trials Office - Baylor University Medical Center - Da     800-422-9567        
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: M. Peter Lance, MD University of Arizona
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Arizona Cancer Center at University of Arizona Health Sciences Center ( M. Peter Lance )
Study ID Numbers: CDR0000353185, UARIZ-00-0430-01, UARIZ-HSC-00142
Study First Received: March 8, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00078897     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer
adenomatous polyp

Additional relevant MeSH terms:
Antioxidants
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Rectal Diseases
Selenium
Neoplasms by Site
Micronutrients
Adenomatous Polyps
Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Trace Elements
Intestinal Diseases
Protective Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009