Fluoxetine versus placebo in advanced cancer outpatients: a double-blinded trial of the Hoosier Oncology Group.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

PURPOSE: To determine whether fluoxetine improves overall quality of life (QOL) in advanced cancer patients with symptoms of depression revealed by a simple survey. PATIENTS AND METHODS: One hundred sixty-three patients with an advanced solid tumor and expected survival between 3 and 24 months were randomly assigned in a double-blinded fashion to receive either fluoxetine (20 mg daily) or placebo for 12 weeks. Patients were screened for at least minimal depressive symptoms and assessed every 3 to 6 weeks for QOL and depression. Patients with recent exposure to antidepressants were excluded. RESULTS: The groups were comparable at baseline in terms of age, sex, disease distribution, performance status, and level of depressive symptoms. One hundred twenty-nine patients (79%) completed at least one follow-up assessment. Analysis using generalized estimating equation modeling revealed that patients treated with fluoxetine exhibited a significant improvement in QOL as shown by the Functional Assessment of Cancer Therapy-General, compared with patients given placebo (P =.01). Specifically, the level of depressive symptoms expressed was lower in patients treated with fluoxetine (P =.0005), and the subgroup of patients showing higher levels of depressive symptoms on the two-question screening survey were the most likely to benefit from treatment. CONCLUSION: In this mix of patients with advanced cancer who had symptoms of depression as determined by a two-question bedside survey, use of fluoxetine was well tolerated, overall QOL was improved, and depressive symptoms were reduced.

Full Text

Duke Authors

Cited Authors

  • Fisch, MJ; Loehrer, PJ; Kristeller, J; Passik, S; Jung, S-H; Shen, J; Arquette, MA; Brames, MJ; Einhorn, LH; Hoosier Oncology Group,

Published Date

  • May 15, 2003

Published In

Volume / Issue

  • 21 / 10

Start / End Page

  • 1937 - 1943

PubMed ID

  • 12743146

Pubmed Central ID

  • 12743146

International Standard Serial Number (ISSN)

  • 0732-183X

Digital Object Identifier (DOI)

  • 10.1200/JCO.2003.08.025


  • eng

Conference Location

  • United States