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Respiratory Ancillary Study (RAS) to SELECT


Phase 3
50 Years
90 Years
Not Enrolling
Male
Pulmonary Disease, Chronic Obstructive, Lung Diseases

Thank you

Trial Information

Respiratory Ancillary Study (RAS) to SELECT


BACKGROUND:

Observational epidemiologic studies provide compelling evidence suggesting that high
antioxidant intake is associated with reduced risk of chronic obstructive pulmonary disease
(COPD) and increased lung function.

DESIGN NARRATIVE:

The purpose of this study is two-fold. First, the study will longitudinally test whether: 1)
the decrease in FEV1 over 3 years is lower among men receiving daily supplementation with
200 µg selenium compared to men receiving placebo; and 2) the decrease in FEV1 over 3 years
is lower among men receiving daily supplementation with both 200 µg selenium and 400 mg
vitamin E compared to men receiving placebo. Second, the study will cross-sectionally test,
at 3 years post-randomization, whether: 1) FEV1 is higher among men receiving daily
supplementation with 200 µg selenium and 400 mg vitamin E compared to men receiving placebo;
and 2) FEV1 is higher among men receiving daily supplementation with 200 µg selenium
compared to men receiving placebo.

The primary outcome of this study will be pulmonary function decline, which will be studied
in 3,000 Selenium and Vitamin E Cancer Prevention Trial (SELECT) men at 18 SELECT sites.

The key secondary outcome will be COPD and asthma occurrence in the 35,000 men of the SELECT
trial. Data on outcome occurrence will be updated at each biannual visit.

This study is an ancillary to the SELECT study (selenium and vitamin E supplements being
studied for effects on prostate cancer prevention), which withdrew supplements from all
participants in October 2008 due to no effect on prostate cancer. Data collection continues
in both SELECT and in this study in the post-supplementation period until researchers have
completed pulmonary function testing (three measurements in 3 years) on all participants.
Ultimately, the trial analysis will examine whether treatment affected the endpoint in the
intervention period, and whether the effect is attenuated in the post-supplementation
period.


Inclusion Criteria:



- Active SELECT participant and on supplements (defined as taking one or both of the
SELECT study supplements)

- Meets the eligibility requirements for registration (e.g., within certain time
windows from annual visits, having signed informed consent for Respiratory Ancillary
Study [RAS], at a site which has concurrent Institutional Review Board [IRB] approval
for RAS)

- Registered at SELECT randomization (within 28 days after SELECT randomization, or at
plus or minus 28 days [within the contact window] of their SELECT annual visits 020,
030, or 040)

- Registered and followed for RAS at the same site at which they are being followed for
SELECT

- Agree to provide a blood and urine sample for submission to central laboratories

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 in forced expiratory volume in first second (FEV1)

Outcome Time Frame:

Measured three times in 36 months

Safety Issue:

No

Principal Investigator

Patricia A. Cassano, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Cornell University

Authority:

United States: Federal Government

Study ID:

331

NCT ID:

NCT00241865

Start Date:

June 2004

Completion Date:

December 2010

Related Keywords:

  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases
  • Chronic Disease
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases, Obstructive

Name

Location

UCSDSan Diego, California  92103
Rush University Medical CenterChicago, Illinois  60612-3824
UT MD Anderson Cancer CenterHouston, Texas  77030
Wichita CCOPWichita, Kansas  67214-3882
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Cornell UniversityNew York, New York  10021
Kansas City VAMCKansas City, Missouri  64128
Moores Cancer Center/UCSDLa Jolla, California  92093
Harbor UCLATorrance, California  90502
VAMC Washington DCWashington, District of Columbia  20422
West Side VA Medical OncologyChicago, Illinois  60612
Minneapolis VAMCMinneapolis, Minnesota  55417
SUNY Stony BrookStony Brook, New York  11733
Swedish HospitalSeattle, Washington  98104
VAMC Puget SoundSeattle, Washington  98108