Reduction of Cancer-Related Fatigue With Dexamethasone: A Double-Blind, Randomized, Placebo-Controlled Trial in Patients With Advanced Cancer

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

+ Author Affiliations

1. Sriram Yennurajalingam, Susan Frisbee-Hume, J. Lynn Palmer, Marvin O. Delgado-Guay, Alexandria T. Phan, Nizar M. Tannir, Jennifer Keating Litton, Akhila Reddy, David Hui, Shalini Dalal, Suresh K. Reddy, and Eduardo Bruera, The University of Texas MD Anderson Cancer Center, Houston, TX; and Janet Bull and Lisa Massie, Four Seasons Hospice, Flat Rock, NC.

1. Corresponding author: Sriram Yennurajalingam, MD, Department of Palliative Care and Rehabilitation Medicine, Unit 1414, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: syennu@mdanderson.org.

© 2013 by American Society of Clinical OncologyAbstract

Purpose 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 and 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).

Conclusion Dexamethasone is more effective than placebo in improving CRF and quality of life in patients with advanced cancer.