title: Reduction of cancer-related fatigue with dexamethasone: a double-blind, randomized, placebo-controlled trial in patients with advanced cancer.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  Dexamethasone is more effective than placebo in improving CRF and quality of life in patients with advanced cancer.
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, USA. syennu@mdanderson.org
authors.forename: Sriram
authors.initials: S
authors.lastname: Yennurajalingam
authors.forename: Susan
authors.initials: S
authors.lastname: Frisbee-Hume
authors.forename: J Lynn
authors.initials: JL
authors.lastname: Palmer
authors.forename: Marvin O
authors.initials: MO
authors.lastname: Delgado-Guay
authors.forename: Janet
authors.initials: J
authors.lastname: Bull
authors.forename: Alexandria T
authors.initials: AT
authors.lastname: Phan
authors.forename: Nizar M
authors.initials: NM
authors.lastname: Tannir
authors.forename: Jennifer Keating
authors.initials: JK
authors.lastname: Litton
authors.forename: Akhila
authors.initials: A
authors.lastname: Reddy
authors.forename: David
authors.initials: D
authors.lastname: Hui
authors.forename: Shalini
authors.initials: S
authors.lastname: Dalal
authors.forename: Lisa
authors.initials: L
authors.lastname: Massie
authors.forename: Suresh K
authors.initials: SK
authors.lastname: Reddy
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bruera
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000523:psychology; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D003907:Dexamethasone