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Prevention of Lung Function Decline With Vitamin E and Selenium - Respiratory Ancillary Study (RAS)


Phase 3
50 Years
N/A
Not Enrolling
Male
Pulmonary Function

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Trial Information

Prevention of Lung Function Decline With Vitamin E and Selenium - Respiratory Ancillary Study (RAS)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Rate of decline of FEV1

Outcome Description:

Assessment of pulmonary function testing (spirometry) at multiple time points over a 3-year period (longitudinal)

Outcome Time Frame:

FEV1 over a 3-year period

Safety Issue:

No

Principal Investigator

Patricia A. Cassano, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Federal Government

Study ID:

CDR0000617786

NCT ID:

NCT00782678

Start Date:

June 2004

Completion Date:

July 2012

Related Keywords:

  • Pulmonary Function
  • pulmonary function

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