S0000 Selenium and Vitamin E in Preventing Prostate Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborators:	National Cancer Institute (NCI) National Center for Complementary and Alternative Medicine (NCCAM) Eastern Cooperative Oncology Group Cancer and Leukemia Group B NCIC Clinical Trials Group
Information provided by:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00006392

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: selenium Dietary Supplement: vitamin E	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer Vitamin E

Drug Information available for: Selenomethionine Tocopherol acetate

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Effect on the clinical incidence of cancer [ Designated as safety issue: No ]
Effect on cancer-free survival, overall survival and serious cardiovascular events [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Association of biological molecular markers with cancer risk [ Designated as safety issue: No ]
Relationship between effects on cancer risk and genetic factors [ Designated as safety issue: No ]
Effects in terms of intake of other nutrients, foods, and dietary supplements [ Designated as safety issue: No ]
Effect of other dietary nutrients and dietary patterns on cancer risk [ Designated as safety issue: No ]
Effects on the reduction of Alzheimer's disease incidence [ Designated as safety issue: No ]
Reduction in the risk of age-related macular degeneration or cataract [ Designated as safety issue: No ]

Study Start Date:

July 2001

Detailed Description:

OBJECTIVES:

Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer.
Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study.
Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.
Compare the quality of life of participants treated with these regimens.
Determine the association of biological molecular markers with the risk of prostate cancer, lung cancer, and colon cancer in these participants.
Determine the relationship between the effects of these regimens on prostate cancer risk and genetic factors in these participants.
Determine whether the effects of these regimens on prostate cancer risk are conditional upon pre-study use of these supplements by these participants.
Determine whether the effects of these regimens are conditional upon intake of other nutrients, foods, and dietary supplements by these participants.
Determine the effect of other dietary nutrients and dietary patterns on prostate cancer risk in these participants.
Determine the effects of these regimens on the reduction of Alzheimer's disease incidence in these participants.
Determine whether these regimens reduce the risk of age-related macular degeneration or cataract in these participants.

OUTLINE: This is a randomized, double-blind, multicenter study. Participants are randomized to one of four prevention arms.

Arm I: Participants receive 2 different oral placebos once daily.
Arm II: Participants receive oral selenium and oral placebo once daily.
Arm III: Participants receive oral vitamin E and oral placebo once daily.
Arm IV: Participants receive oral selenium and oral vitamin E once daily. Treatment continues for 7-12 years in the absence of unacceptable toxicity or diagnosis of prostate cancer.

Quality of life is assessed at baseline and then at 1, 3, 5, and 7 years.

Participants are followed annually.

PROJECTED ACCRUAL: A total of 32,400 participants (8,100 per prevention arm) will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Healthy male volunteers
Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry
- Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer
Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry
No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia

PATIENT CHARACTERISTICS:

Age:

See Disease Characteristics

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Cardiovascular:

Systolic blood pressure < 160 mm Hg
Diastolic blood pressure < 90 mm Hg
No history of hemorrhagic stroke

Other:

No malignancies within the past 5 years except basal cell or squamous cell skin cancer
No uncontrolled medical illness
No retinitis pigmentosa

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement
No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)
Concurrent multivitamins allowed (supplied on study)
No concurrent anticoagulation therapy (e.g., warfarin)
Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed
- Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel
Concurrent anti-hypertension medication allowed
No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006392

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Ohio
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, United States, 45220
Tod Children's Hospital
Youngstown, Ohio, United States, 44501
United States, Oklahoma
LaFortune Cancer Center at St. John Medical Center
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Tennessee
U.T. Cancer Institute at University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920-6999

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

National Center for Complementary and Alternative Medicine (NCCAM)

Eastern Cooperative Oncology Group

Cancer and Leukemia Group B

NCIC Clinical Trials Group

Investigators

Study Chair:	Eric Klein, MD	The Cleveland Clinic
Study Chair:	Michael B. Atkins, MD	Beth Israel Deaconess Medical Center
Study Chair:	Philip J. Walther, MD, PhD	Duke University
Study Chair:	Laurence H. Klotz, MD	Edmond Odette Cancer Centre at Sunnybrook

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

Publications:

Lippman SM, Klein EA, Goodman PJ, Lucia MS, Thompson IM, Ford LG, Parnes HL, Minasian LM, Gaziano JM, Hartline JA, Parsons JK, Bearden JD 3rd, Crawford ED, Goodman GE, Claudio J, Winquist E, Cook ED, Karp DD, Walther P, Lieber MM, Kristal AR, Darke AK, Arnold KB, Ganz PA, Santella RM, Albanes D, Taylor PR, Probstfield JL, Jagpal TJ, Crowley JJ, Meyskens FL Jr, Baker LH, Coltman CA Jr. Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2009 Jan 7;301(1):39-51. Epub 2008 Dec 9.

Hoque A, Albanes D, Lippman SM, Spitz MR, Taylor PR, Klein EA, Thompson IM, Goodman P, Stanford JL, Crowley JJ, Coltman CA, Santella RM. Molecular epidemiologic studies within the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Cancer Causes Control. 2001 Sep;12(7):627-33.

El-Bayoumy K. The negative results of the SELECT study do not necessarily discredit the selenium-cancer prevention hypothesis. Nutr Cancer. 2009;61(3):285-6. No abstract available.

Cook ED, Moody-Thomas S, Anderson KB, Campbell R, Hamilton SJ, Harrington JM, Lippman SM, Minasian LM, Paskett ED, Craine S, Arnold KB, Probstfield JL. Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Clin Trials. 2005;2(5):436-42.

Kristal AR, King IB, Albanes D, Pollak MN, Stanzyk FZ, Santella RM, Hoque A. Centralized blood processing for the selenium and vitamin E cancer prevention trial: effects of delayed processing on carotenoids, tocopherols, insulin-like growth factor-I, insulin-like growth factor binding protein 3, steroid hormones, and lymphocyte viability. Cancer Epidemiol Biomarkers Prev. 2005 Mar;14(3):727-30.

Lippman SM, Goodman PJ, Klein EA, Parnes HL, Thompson IM Jr, Kristal AR, Santella RM, Probstfield JL, Moinpour CM, Albanes D, Taylor PR, Minasian LM, Hoque A, Thomas SM, Crowley JJ, Gaziano JM, Stanford JL, Cook ED, Fleshner NE, Lieber MM, Walther PJ, Khuri FR, Karp DD, Schwartz GG, Ford LG, Coltman CA Jr. Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT). J Natl Cancer Inst. 2005 Jan 19;97(2):94-102.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011 Oct 12;306(14):1549-56.

Chlebowski RT, Menon R, Chaisanguanthum RM, Jackson DM. Prospective evaluation of two recruitment strategies for a randomized controlled cancer prevention trial. Clin Trials. 2010 Dec;7(6):744-8. Epub 2010 Sep 10.

Cook ED, Arnold KB, Hermos JA, McCaskill-Stevens W, Moody-Thomas S, Probstfield JL, Hamilton SJ, Campbell RD, Anderson KB, Minasian LM. Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial. Clin Trials. 2010;7(1):90-9.

Responsible Party:	Laurence H. Baker, D.O., Chairman, SWOG
ClinicalTrials.gov Identifier:	NCT00006392 History of Changes
Obsolete Identifiers:	NCT00076128
Other Study ID Numbers:	CDR0000068277, U10CA032102, S0000, CAN-NCIC-S0000, CALGB-S0000, ECOG-S0000, NCCAM, NCI-P00-0172
Study First Received:	October 4, 2000
Last Updated:	July 21, 2011
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:

prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Selenium
Vitamin E
Alpha-Tocopherol
Tocopherols

Tocotrienols
Vitamins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 20, 2012