Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597.

ABSTRACT:

Purpose

Selenium has been reported to have chemopreventive benefits in lung cancer. We conducted a double-blind, placebo-controlled trial to evaluate the incidence of second primary tumors (SPTs) in patients with resected non-small-cell lung cancer (NSCLC) receiving selenium supplementation.

Patients and methods

Patients with completely resected stage I NSCLC were randomly assigned to take selenized yeast 200 μg versus placebo daily for 48 months. Participation was 6 to 36 months postoperatively and required a negative mediastinal node biopsy, no excessive vitamin intake, normal liver function, negative chest x-ray, and no other evidence of recurrence.

Results

The first interim analysis in October 2009, with 46% of the projected end points accumulated, showed a trend

SUBMITTER: Karp DD 

PROVIDER: S-EPMC3821010 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature