Selenium for Prevention of Adenomatous Colorectal Polyps

NCT00078897 | Terminated Phase 3 Results DMC

• 3 other identifiers: CDR0000353185P30CA023074P01CA041108
• Study Type: interventional
• Target: 1,621
• Locations: 1 country
• Sites: 7

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.

Conditions

Colorectal Cancer; Adenomatous Colorectal Polyps; Precancerous Condition

Keywords

colon cancer; rectal cancer; colorectal cancer; adenomatous polyp

Outcome Measures

Primary Outcomes (2)

• Number of Recurrent Adenomas at Surveillance 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.

  3 to 5 years after baseline colonoscopy

• Median Selenium Blood Levels at One Year.

  Adequate adherence to long-term selenium treatment as measured by blood selenium levels (ng/mL) at one year.

  One year

Study Arms (2)

Selenium

ACTIVE COMPARATOR

Participants receive oral selenium 200 mcg once daily.

Drug: Selenium

Placebo

PLACEBO COMPARATOR

Participants receive oral placebo once daily.

Drug: Selenium

Interventions

Selenium DRUG

Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.

Also known as: SelenoExcell

Placebo; Selenium

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 (For the Advanced Adenoma Sub-study: Removal of at least 1 advanced colorectal adenomatous polyp during procedure. An adenoma is considered advanced if it is 10 mm or greater in size, and/or has villous histology and/or shows high grade dysplasia) * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Veterans Affairs Medical Center - Phoenix

Phoenix, Arizona, 85012, United States

Location

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85258-4512, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Arizona Cancer Center - Tucson Clinic

Tucson, Arizona, 85724-5024, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Denver, Colorado, 80220, United States

Location

Endoscopy Center of Western New York

Williamsville, New York, 14221, United States

Location

Baylor University Medical Center - Dallas

Dallas, Texas, 75246, United States

Location

Related Publications (4)

• Trejo MJ, Batai K, Chen Y, Brezina S, Chow HS, Ellis N, Lance P, Hsu CH, Pogreba-Brown K, Bishop M, Gsur A, Jacobs ET. Genome-Wide Association Study of Metachronous Colorectal Adenoma Risk among Participants in the Selenium Trial. Nutr Cancer. 2023;75(1):143-153. doi: 10.1080/01635581.2022.2096910. Epub 2022 Jul 9.

  PMID: 35815403 DERIVED

• Jacobs ET, Lance P, Mandarino LJ, Ellis NA, Chow HS, Foote J, Martinez JA, Hsu CP, Batai K, Saboda K, Thompson PA. Selenium supplementation and insulin resistance in a randomized, clinical trial. BMJ Open Diabetes Res Care. 2019 Feb 7;7(1):e000613. doi: 10.1136/bmjdrc-2018-000613. eCollection 2019.

  PMID: 30899530 DERIVED

• Thompson P, Roe DJ, Fales L, Buckmeier J, Wang F, Hamilton SR, Bhattacharyya A, Green S, Hsu CH, Chow HH, Ahnen DJ, Boland CR, Heigh RI, Fay DE, Martinez ME, Jacobs E, Ashbeck EL, Alberts DS, Lance P. Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention. Cancer Prev Res (Phila). 2012 Dec;5(12):1381-93. doi: 10.1158/1940-6207.CAPR-12-0204. Epub 2012 Oct 11.

  PMID: 23060037 DERIVED

• Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31.

  PMID: 18378608 DERIVED

Related Links

• Journal Article

MeSH Terms

Conditions

Colorectal Neoplasms; Precancerous Conditions; Colonic Neoplasms; Rectal Neoplasms; Adenomatous Polyps

Interventions

Selenium

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Results Point of Contact

• Title: Dr. Elizabeth Jacobs
• Organization: University of Arizona

jacobse@email.arizona.edu

(520) 626-0341

Study Officials

• M. Peter Lance, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 9, 2004
• Study Start: January 20, 2005
• Primary Completion: January 7, 2014
• Study Completion: May 17, 2018
• Last Updated: September 24, 2019
• Results First Posted: September 24, 2019

Record last verified: 2019-09

Locations

US (7)