(CHICAGO, IL) – Dexamethasone is more effective than placebo in reducing cancer-related fatigue (CRF) in patients with advanced cancer, according to a clinical trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.
Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered, placebo-controlled trials that used a validated CRF outcome measure, wrote lead author Sriram Yennu, MD, Assistant Professor, Department of Palliative Care and Rehabilitation Medicine, Division of Cancer Medicine, The University of Texas M.D. Anderson Cancer Center, in Houston, TX.
Investigators conducted this prospective, randomized, double-blind, placebo-controlled study to compare the effect of dexamethasone vs. placebo on CRF. Patients were included in the study if they had advanced cancer; CRF ≥4/10 on the Edmonton Symptom Assessment Scale (ESAS); 2 or more other CRF-related symptoms (e.g., pain, nausea, appetite, depression, anxiety or sleep disturbance ≥4/10); normal cognition; no infections, diabetes or recent surgery; hemoglobin ≥9g/dl; and life expectancy of 4 weeks or more.
Patients were randomized to receive either dexamethasone (4mg, orally, twice daily for 14 days) or a matching placebo. Changes in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores from baseline to Day 15 were compared for placebo and dexamethasone using two-sample t-test.
In 83 evaluable patients, median age 60 years, the mean (SD) FACIT-F subscores at baseline and at Day 15 for dexamethasone were 18 and 27 (P<0.001) and for placebo were 21 and 24 (P=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the dexamethasone group compared with placebo (9.6 (11) vs. 3.1 (9.7), P=0.005). Dr. Yennu and colleagues found a significant difference between dexamethasone and placebo in ESAS physical distress (P=0.02), but no differences in ESAS overall symptom distress (P=0.11) and ESAS psychological distress (P=0.88).
No significant differences were reported for grade ≥3 toxicities in patients who received dexamethasone than in patients who received placebo (20/42 vs. 18/47, P=0.37).
Based on these data, Dr. Yennu concluded that dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer, but long-term safety studies are needed to further support this conclusion.