Fluoxetine versus placebo in advanced cancer outpatients: a double-blinded trial of the Hoosier Oncology Group.
OBJECTIVE
To determine whether fluoxetine improves overall quality of life (QOL) in advanced cancer patients with symptoms of depression revealed by a simple survey.


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.


CONCLUSIONS
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.
Department of Palliative Care and Rehabilitation, University of Texas M.D. Anderson Cancer Center, Box 008, Room P12.2911, 1515 Holcombe Blvd, Houston, TX 77030-4009, USA. mfisch@mdanderson.org
Michael J
MJ
Fisch
Patrick J
PJ
Loehrer
Jean
J
Kristeller
Steven
S
Passik
Sin-Ho
SH
Jung
Jianzhao
J
Shen
Matthew A
MA
Arquette
Mary J
MJ
Brames
Lawrence H
LH
Einhorn
D000553:Ambulatory Care; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage / Q000627:therapeutic use*; D003863:Depression / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007196:Indiana; D007629:Kentucky; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000401:mortality / Q000523:psychology*; D009657:North Carolina; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D013781:Texas; D016896:Treatment Outcome; D014861:Washington
D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine