Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial
| Autor: | Anne Tsao, Eduardo Bruera, William N. William, Marvin Delgado Guay, Kelly Kilgore, Sapna Amin, David Hui, Katherine M.W. Pisters, Charles Lu, Frank V. Fossella, George A. Eapen, Susan Frisbee-Hume, Minjeong Park |
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| Rok vydání: | 2015 |
| Předmět: |
Spirometry
Male Anti-Inflammatory Agents Context (language use) Pilot Projects Placebo Severity of Illness Index Dexamethasone Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life Double-Blind Method law Neoplasms Severity of illness medicine Humans 030212 general & internal medicine General Nursing Aged medicine.diagnostic_test business.industry Cancer Middle Aged medicine.disease Anesthesiology and Pain Medicine Dyspnea Treatment Outcome 030220 oncology & carcinogenesis Anesthesia Quality of Life Feasibility Studies Female Neurology (clinical) Sleep Stages business medicine.drug |
| Zdroj: | Journal of pain and symptom management. 52(1) |
| ISSN: | 1873-6513 |
| Popis: | 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.gov NCT01670097. |
| Databáze: | OpenAIRE |
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