David Hui1, Kelly Kilgore2, Susan Frisbee-Hume2, Minjeong Park3, Anne Tsao4, Marvin Delgado Guay2, Charles Lu4, William William4, Katherine Pisters4, George Eapen5, Frank Fossella4, Sapna Amin2, Eduardo Bruera2. 1. Department of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org. 2. Department of Palliative Care and Rehabilitation Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA. 3. Department of Biostatistics, M. D. Anderson Cancer Center, Houston, Texas, USA. 4. Department of Thoracic Medical Oncology, M. D. Anderson Cancer Center, Houston, Texas, USA. 5. Department of Pulmonary Medicine, M. D. Anderson Cancer Center, Houston, Texas, USA.
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.
RCT Entities:
CONTEXT: Dexamethasone is often used to treat dyspnea in cancerpatients, but evidence is lacking. OBJECTIVES: We determined the feasibility of conducting a randomized trial of dexamethasone in cancerpatients 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.
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