| Selenium and Vitamin E in Preventing Prostate Cancer
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Prevention | Closed | 55 and over (50 and over for African Americans) | CDR0000068277
SWOG-S0000, CAN-NCIC-S0000, CALGB-S0000, ECOG-S0000, NCCAM, NCI-P00-0172, NCT00006392 |
Trial Description
Summary 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. Further Study Information 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 Criteria DISEASE CHARACTERISTICS: - 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: Life expectancy: Hematopoietic: Hepatic: Renal: 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
PRIOR CONCURRENT THERAPY: Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery 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)
Trial Contact Information
Trial Lead Organizations/Sponsors Southwest Oncology Group National Cancer Institute
National Center for Complementary and Alternative Medicine
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
NCIC-Clinical Trials Group
| Eric Klein |  | Study Chair |
| Michael Benjamin Atkins | | Study Chair |
| Philip J. Walther | | Study Chair |
| Laurence H. Klotz | | Study Chair |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00006392
Information obtained from ClinicalTrials.gov on January 20, 2010 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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