Reduction of cancer-related fatigue with dexamethasone: A double-blind, randomized, placebo-controlled trial in patients with advanced cancer

Sriram Yennurajalingam, Susan Frisbee-Hume, J. Lynn Palmer, Marvin O. Delgado-Guay, Janet Bull, Alexandria T. Phan, Nizar M. Tannir, Jennifer Keating Litton, Akhila Reddy, David Hui, Shalini Dalal, Lisa Massie, Suresh K. Reddy, Eduardo Bruera

Research output: Contribution to journalArticle

180 Scopus citations

Abstract

Cancer-related fatigue (CRF) is the most common symptom in patients with advanced cancer. The primary objective of this prospective, randomized, double-blind, placebo-controlled study was to compare the effect of dexamethasone and placebo on CRF. Patients with advanced cancer with ≥ three CRF-related symptoms (ie, fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance) ≥ 4 of 10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible. Patients were randomly assigned to either dexamethasone 4 mg or placebo orally twice per day for 14 days. The primary end point was change in the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale from baseline to day 15. Secondary outcomes included anorexia, anxiety, depression, and symptom distress scores. A total of 84 patients were evaluable (dexamethasone, 43; placebo, 41). Mean (± standard deviation) improvement in the FACIT-F subscale at day 15 was significantly higher in the dexamethasone than in the placebo group (9 [± 10.3] v 3.1 [± 9.59]; P = .008). The improvement in FACIT-F total quality-of-life scores was also significantly better for the dexamethasone group at day 15 (P = .03). The mean differences in the ESAS physical distress scores at day 15 were significantly better for the dexamethasone group (P = .013, respectively). No differences were observed for ESAS overall symptom distress (P = .22) or psychological distress score (P = .76). Frequency of adverse effects was not significantly different between groups (41 of 62 v 44 of 58; P = .14). Dexamethasone is more effective than placebo in improving CRF and quality of life in patients with advanced cancer.

Original languageEnglish (US)
Pages (from-to)3076-3082
Number of pages7
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume31
Issue number25
DOIs
StatePublished - Sep 1 2013

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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