Trial record 9 of 166 for:    selenium

S0000C Vitamin E and/or Selenium in Preventing Loss of Lung Function in Older Men Enrolled on SELECT Clinical Trial SWOG-S0000

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00782678
First received: October 29, 2008
Last updated: June 13, 2013
Last verified: June 2013
  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 Phase
Pulmonary Function
Drug: selenium
Drug: vitamin E
Drug: Vitamin E placebo
Drug: Selenium placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Lung Function Decline With Vitamin E and Selenium - Respiratory Ancillary Study (RAS)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Rate of decline of FEV1 [ Time Frame: FEV1 over a 3-year period ] [ Designated as safety issue: No ]
    Assessment of pulmonary function testing (spirometry) at multiple time points over a 3-year period (longitudinal)

  • FEV1 at 3 years post randomization [ Time Frame: 3-years ] [ Designated as safety issue: No ]
    Single pulmonary function testing (spirometry) at year 3 (cross-sectional)


Secondary Outcome Measures:
  • Differences in FEV1 between vitamin E vs.placebo and combination vs. placebo [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Longitudinal and cross-sectional differences in FEV1 as measured by pulmonary function tests (spirometry)

  • Effect of vitamin E and/or selenium on pulmonary function of smokers vs. non-smokers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Longitudinal and cross-sectional differences in FEV1 as measured by pulmonary function tests (spirometry)

  • Pattern of response of FEV1 to supplementation by vitamin E and/or selenium [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Characterize the shape of treatment response; measured on a subset of 100 men.

  • Effect of supplementation with vitamin E and/or selenium on oxidative stress indicators [ Time Frame: Urine sample at year 3 ] [ Designated as safety issue: No ]
    Measures of urinary F2-isoprostanes

  • Collection of blood samples for future investigation of additional markers of oxidative stress [ Time Frame: Blood sample at year 3 ] [ Designated as safety issue: No ]
    Examples of potential biomarkers includes plasma oxidized low-density lipoproteins


Enrollment: 2921
Study Start Date: June 2004
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
Drug: vitamin E
400 IU daily for 7-12 years
Other Name: alpha tocopherol
Drug: Selenium placebo
1 pill daily for 7-12 years
Other Name: placebo
Experimental: Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
Drug: selenium
200 micrograms daily for 7-12 years
Other Name: L-selenomethionine
Drug: Vitamin E placebo
1 pill daily for 7-12 years
Other Name: placebo
Experimental: Vitamin E + selenium
vitamin E and selenium for 7 - 12 years
Drug: selenium
200 micrograms daily for 7-12 years
Other Name: L-selenomethionine
Drug: vitamin E
400 IU daily for 7-12 years
Other Name: alpha tocopherol
Placebo Comparator: Vitamin E placebo + selenium placebo
vitamin E placebo and selenium placebo daily for 7-12 years
Drug: Vitamin E placebo
1 pill daily for 7-12 years
Other Name: placebo
Drug: Selenium placebo
1 pill daily for 7-12 years
Other Name: placebo

Detailed Description:

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

INCLUSION:

  • Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT) SWOG-S0000
  • On treatment and receiving supplementation with selenium and/or vitamin E

EXCLUSION:

  • Participants who are no longer taking either study supplement are excluded

PATIENT CHARACTERISTICS:

  • Agrees to provide blood and urine samples for submission to a central lab

PRIOR CONCURRENT THERAPY:

  • NA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782678

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Patricia A. Cassano, PhD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00782678     History of Changes
Other Study ID Numbers: CDR0000617786, U10CA012027, S0000C, U10CA037429
Study First Received: October 29, 2008
Last Updated: June 13, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
pulmonary function

Additional relevant MeSH terms:
Selenium
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014