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.