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Randomized Controlled Trial
. 2016 Jul;52(1):8-16.e1.
doi: 10.1016/j.jpainsymman.2015.10.023. Epub 2016 Jun 18.

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

David Hui  1 , Kelly Kilgore  2 , Susan Frisbee-Hume  2 , Minjeong Park  3 , Anne Tsao  4 , Marvin Delgado Guay  2 , Charles Lu  4 , William William Jr  4 , Katherine Pisters  4 , George Eapen  5 , Frank Fossella  4 , Sapna Amin  2 , Eduardo Bruera  2
Affiliations
Randomized Controlled Trial

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

David Hui et al. J Pain Symptom Manage. 2016 Jul.

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 × four days then 4 mg twice daily × 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), 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 numeric rating scale of -1.9 (95% 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.

Trial registration: ClinicalTrials.govNCT01670097.

Keywords: Dexamethasone; dyspnea; neoplasms; pharmacologic therapy; pilot study; quality of life; randomized controlled trial.

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Conflict of interest statement

Disclosures: The authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1. CONSORT diagram
See this image and copyright information in PMC

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