S0000C Vitamin E and/or Selenium in Preventing Loss of Lung Function in Older Men Enrolled on SELECT Clinical Trial SWOG-S0000
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Southwest Oncology Group.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00782678
First received: October 29, 2008
Last updated: July 21, 2011
Last verified: October 2008
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Purpose
RATIONALE: Aging may affect a person's lung function. Vitamin E and/or selenium may help prevent loss of lung function in older men receiving these drugs for the prevention of prostate cancer.
PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work in preventing loss of lung function in older men enrolled on SELECT clinical trial SWOG-S0000.
| Condition | Intervention |
|---|---|
|
Pulmonary Complications |
Dietary Supplement: selenium Dietary Supplement: vitamin E Other: biologic sample preservation procedure Other: laboratory biomarker analysis Other: physiologic testing Other: questionnaire administration |
| Study Type: | Interventional |
| Official Title: | Prevention of Lung Function Decline With Vitamin E and Selenium - Respiratory Ancillary Study (RAS) |
Resource links provided by NLM:
MedlinePlus related topics:
Vitamin E
Drug Information available for:
alpha-Tocopherol
Tocopherol
Selenomethionine
Vitamin E succinate
Tocopherol acetate
dl-alpha-Tocopherol
U.S. FDA Resources
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Rate of decline of FEV1 over a 3-year period as assessed by pulmonary function testing (spirometry) [ Designated as safety issue: No ]
- Cross-sectional assessment of FEV1 at 3 years post randomization [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Longitudinal and cross-sectional differences in FEV1 [ Designated as safety issue: No ]
- Differences in the effects of intervention based on current smoking dose or pack-years of exposure [ Designated as safety issue: No ]
- Graphical characterization of the shape of treatment response [ Designated as safety issue: No ]
- Effect of daily supplementation with selenium and vitamin E in a subgroup of current smokers as measured by oxidative stress biomarkers (e.g., urinary F2-isoprostanes) [ Designated as safety issue: No ]
- Collection of blood samples for future investigation of additional markers of oxidative stress (e.g., plasma oxidized low-density lipoproteins) [ Designated as safety issue: No ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | June 2004 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To test longitudinally whether the decrease in FEV_1 over 3 years is lower among men receiving daily supplementation with selenium compared to men receiving placebo on SELECT clinical trial SWOG-S0000.
- To test longitudinally whether the decrease in FEV_1 over 3 years is lower among men receiving daily supplementation with both selenium and vitamin E compared to men receiving placebo.
- To test cross-sectionally whether FEV_1 is higher at 3 years post randomization among men receiving daily supplementation with both selenium and vitamin E compared to men receiving placebo.
- To test cross-sectionally whether FEV_1 is higher at 3 years post randomization among men receiving daily supplementation with selenium compared to men receiving placebo.
Secondary
- To test longitudinally and cross-sectionally whether there is a difference in FEV_1 among men receiving daily supplementation with vitamin E compared to men receiving placebo.
- To test longitudinally and cross-sectionally whether there is a difference in FEV_1 among men receiving daily supplementation with both selenium and vitamin E compared to men receiving selenium alone or vitamin E alone.
- To evaluate the effect of daily supplementation with selenium and/or vitamin E in a subgroup of current smokers.
- To characterize the shape of the early response of FEV_1 to supplement use in a subset of participants.
- To evaluate whether the effect of daily supplementation with selenium and vitamin E in a subgroup of current smokers is mediated by the level of oxidative stress as measured by urinary F2-isoprostanes.
- To collect blood samples to allow future investigation of additional markers of oxidative stress, including oxidized lipoproteins, to understand whether proposed mediated pathways indeed explain intervention effects.
OUTLINE: This is a multicenter study.
Participants undergo pulmonary function testing by spirometer and complete a questionnaire on respiratory symptoms at baseline and then periodically for up to 3 years. Participants also undergo urine and blood sample collection for evaluation of oxidative stress biomarkers (e.g., urinary F2-isoprostanes and plasma oxidized low-density lipoproteins). Blood samples will be stored for future research studies.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
DISEASE CHARACTERISTICS:
- Healthy participant
Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT) SWOG-S0000
- Receiving supplementation with selenium and/or vitamin E
PATIENT CHARACTERISTICS:
- Agrees to provide blood and urine samples for submission to a central lab
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Laurence H. Baker, D.O., Chairman, SWOG |
| ClinicalTrials.gov Identifier: | NCT00782678 History of Changes |
| Other Study ID Numbers: | CDR0000617786, U10CA012027, SWOG-S0000C |
| Study First Received: | October 29, 2008 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Southwest Oncology Group:
|
pulmonary complications |
Additional relevant MeSH terms:
|
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 22, 2013