Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial

• Published in: Journal of pain and symptom management Vol. 52; no. 1; pp. 8 - 16.e1
• Main Authors: Hui, David, MD, MSc, Kilgore, Kelly, BS, Frisbee-Hume, Susan, MS, Park, Minjeong, PhD, Tsao, Anne, MD, Delgado Guay, Marvin, MD, Lu, Charles, MD, William, William, MD, Pisters, Katherine, MD, Eapen, George, MD, Fossella, Frank, MD, Amin, Sapna, PharmD, Bruera, Eduardo, MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2016
• Subjects: Aged; Anesthesia & Perioperative Care; Anti-Inflammatory Agents - therapeutic use; Dexamethasone; Dexamethasone - therapeutic use; Double-Blind Method; dyspnea; Dyspnea - complications; Dyspnea - drug therapy; Feasibility Studies; Female; Humans; Male; Middle Aged; neoplasms; Neoplasms - complications; Neoplasms - drug therapy; Pain Medicine; pharmacologic therapy; Pilot Projects; pilot study; Quality of Life; randomized controlled trial; Severity of Illness Index; Sleep Stages - drug effects; Spirometry; Treatment Outcome; United States > US; dexamethasone; pharmacologic therapy; pilot study; dyspnea; neoplasms; quality of life; randomized controlled trial; Dexamethasone
• ISSN: 0885-3924; 1873-6513
• DOI: 10.1016/j.jpainsymman.2015.10.023

Abstract Context Dexamethasone is often used to treat dyspnea in cancer patients but evidence is lacking. Objectives We determined the feasibility of conducting a randomized trial of dexamethasone in cancer patients, and estimated the efficacy of dexamethasone in the treatment of dyspnea. Methods In this double-blind, randomized, controlled trial, patients with dyspnea ≥4 were randomized to receive either dexamethasone 8 mg twice daily x four days then 4 mg twice daily x three days or placebo for seven days, followed by an open-label phase for seven days. We documented the changes in dyspnea (0-10 numeric rating scale [NRS]), spirometry measures, quality of life and toxicities. Results A total of 41 patients were randomized and 35 (85%) completed the blinded phase. Dexamethasone was associated with a significant reduction in dyspnea NRS of -1.9 (95% confidence interval [CI] -3.3 to -0.5, P =0.01) by day 4 and -1.8 (95% CI -3.2 to -0.3, P =0.02) by day 7. In contrast, placebo was associated with a reduction of -0.7 (95% CI -2.1 to 0.6, P =0.38) by day 4 and -1.3 (95% CI -2.4 to -0.2, P =0.03) by day 7. The between-arm difference was not statistically significant. Drowsiness improved with dexamethasone. Dexamethasone was well tolerated with no significant toxicities. Conclusion A double-blind, randomized, controlled trial of dexamethasone was feasible with a low attrition rate. Our preliminary data suggest that dexamethasone may be associated with rapid improvement in dyspnea and was well tolerated. Further studies are needed to confirm our findings.