Yennurajalingam, S., Frisbee-Hume, S., Palmer, J.L., Delgado-Guay, M.O., Bull, J., Phan, A.T., . . . Bruera, E. (2013). Reduction of cancer-related fatigue with dexamethasone: A double-blind, randomized, placebo-controlled trial in patients with advanced cancer. Journal of Clinical Oncology, 31, 3076–3082. 

Compare the effect of dexamethasone and placebo on cancer-related fatigue (CRF) and quality of life.

Dexamethasone 4 mg or placebo orally twice a day for 14 days.

• N = 84
• AVERAGE AGE: 60 years
• MALES: 47%, FEMALES: 53%  
• KEY DISEASE CHARACTERISTICS: Advanced multiple site-specific cancers: breast, lung, colon, prostate, other
• OTHER KEY SAMPLE CHARACTERISTICS: Three or more concurrent signs/symptoms in past 24 hours with a 4 or greater score for severity on the symptom scale

• SITE: Multi-site  
• SETTING TYPE: Outpatient    
• LOCATION: MD Anderson Cancer Center or Lyndon B. Johnson General Hospital

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Elder care, palliative care 

• Randomized, double-blinded, placebo-controlled trial

• Edmonton Symptom Assessment Scale (ESAS)
• Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)
• Functional Assessment of Anorexia/Cachexia Therapy (FAACT)
• Hospital Anxiety and Depression (HADS) questionnaire
• NCI Common Toxicity Criteria (v.3.0)

Dexamethasone and placebo groups had no differences in patient characteristics at baseline with the exception of more females in the dexamethasone group. Mean improvement scores of the FACIT-F subscale scores and ESAS physical distress scores were significantly better in the dexamethasone than the placebo group at days 8 (p = .005) and 15 (p = .008). ESAS pain was significantly better in the dexamethasone group on day 8. FAACT subscale scores were significantly better in the dexamethasone group on day 15. Fatigue did decline in both study groups. All other variables showed no significant differences in scores or frequency of adverse events.

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

• Small sample (< 100)
• Key sample group differences that could influence results
• Subject withdrawals were 10% or greater
• Other limitations/explanation: Adherence to schedule and actual taking of dexamethasone was not reported. It was unclear why patients with gastrointestinal or head and neck cancers were grouped in reporting sample characteristics. Limited justification of dose or schedule choice for administration of dexamethasone. The dropout rate was 34/120 subjects, as noted in the manuscript, although a sample size listed in a table was 132 subjects.

A need exists for larger, long-term studies to determine safety and efficacy in patients with cancer (palliative care and active treatment). A significant number of patients with advanced cancer present with multiple signs and symptoms that may or may not benefit from dexamethasone therapy. Clinicians should be aware of barriers to adherence with dexamethasone.