title: Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial.
abstract: Dexamethasone is often used to treat dyspnea in cancer patients, but evidence is lacking.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.govNCT01670097.
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.
authors.forename: David
authors.initials: D
authors.lastname: Hui
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Kilgore
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Frisbee-Hume
authors.affiliation: Department of Biostatistics, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Minjeong
authors.initials: M
authors.lastname: Park
authors.affiliation: Department of Thoracic Medical Oncology, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Tsao
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Marvin
authors.initials: M
authors.lastname: Delgado Guay
authors.affiliation: Department of Thoracic Medical Oncology, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Lu
authors.affiliation: Department of Thoracic Medical Oncology, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: William
authors.initials: W
authors.lastname: William
authors.affiliation: Department of Thoracic Medical Oncology, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Katherine
authors.initials: K
authors.lastname: Pisters
authors.affiliation: Department of Pulmonary Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: George
authors.initials: G
authors.lastname: Eapen
authors.affiliation: Department of Thoracic Medical Oncology, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Fossella
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Sapna
authors.initials: S
authors.lastname: Amin
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bruera
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D004417:Dyspnea / Q000150:complications* / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D010865:Pilot Projects; D011788:Quality of Life; D012720:Severity of Illness Index; D012894:Sleep Stages / Q000187:drug effects; D013147:Spirometry; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D003907:Dexamethasone
keywords: Dexamethasone; dyspnea; neoplasms; pharmacologic therapy; pilot study; quality of life; randomized controlled trial