TY - JOUR
T1 - Dexamethasone for Dyspnea in Cancer Patients
T2 - A Pilot Double-Blind, Randomized, Controlled Trial
AU - Hui, David
AU - Kilgore, Kelly
AU - Frisbee-Hume, Susan
AU - Park, Minjeong
AU - Tsao, Anne
AU - Delgado Guay, Marvin
AU - Lu, Charles
AU - William, William
AU - Pisters, Katherine
AU - Eapen, George
AU - Fossella, Frank
AU - Amin, Sapna
AU - Bruera, Eduardo
N1 - Publisher Copyright:
© 2016 American Academy of Hospice and Palliative Medicine
PY - 2016/7/1
Y1 - 2016/7/1
N2 - 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.
AB - 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.
KW - Dexamethasone
KW - dyspnea
KW - neoplasms
KW - pharmacologic therapy
KW - pilot study
KW - quality of life
KW - randomized controlled trial
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U2 - 10.1016/j.jpainsymman.2015.10.023
DO - 10.1016/j.jpainsymman.2015.10.023
M3 - Article
C2 - 27330023
AN - SCOPUS:84991218714
SN - 0885-3924
VL - 52
SP - 8-16.e1
JO - Journal of pain and symptom management
JF - Journal of pain and symptom management
IS - 1
ER -