Selenium and Vitamin E in Preventing Prostate Cancer
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) July 2007
| Sponsors and Collaborators: |
Southwest Oncology Group
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
National Cancer Institute of Canada |
| Information provided by: |
National Cancer Institute (NCI) |
| 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
|
Drug: selenium
Drug: vitamin E
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: chemoprevention of cancer
Procedure: complementary and alternative therapy
Procedure: nutritional supplementation
|
Phase III
|
MedlinePlus
related topics:
Prostate Cancer
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control
Official Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Further study details as provided by National Cancer Institute (NCI):
Study start: July 2001
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.
Fore more Information on Prostate Study, Click Here
