Dataset Information

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.

SUBMITTER: Hui D

PROVIDER: S-EPMC4958556 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial.

Hui David D Kilgore Kelly K Frisbee-Hume Susan S Park Minjeong M Tsao Anne A Delgado Guay Marvin M Lu Charles C William William W Pisters Katherine K Eapen George G Fossella Frank F Amin Sapna S Bruera Eduardo E

Journal of pain and symptom management 20160618 1

<h4>Context</h4>Dexamethasone is often used to treat dyspnea in cancer patients, but evidence is lacking.<h4>Objectives</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 27330023

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Project description:ObjectiveIn the absence of controlled trials, treatment of neonatal seizures has changed minimally despite poor drug efficacy. We tested bumetanide added to phenobarbital to treat neonatal seizures in the first trial to include a standard-therapy control group.MethodsA randomized, double-blind, dose-escalation design was employed. Neonates with postmenstrual age 33 to 44 weeks at risk of or with seizures were eligible. Subjects with electroencephalography (EEG)-confirmed seizures after ≥20 and <40mg/kg phenobarbital were randomized to receive additional phenobarbital with either placebo (control) or 0.1, 0.2, or 0.3mg/kg bumetanide (treatment). Continuous EEG monitoring data from ≥2 hours before to ≥48 hours after study drug administration (SDA) were analyzed for seizures.ResultsSubjects were randomized to treatment (n = 27) and control (n = 16) groups. Pharmacokinetics were highly variable among subjects and altered by hypothermia. The only statistically significant adverse event was diuresis in treated subjects (48% vs 13%, p = 0.02). One treated (4%) and 3 control subjects died (19%, p = 0.14). Among survivors, 2 of 26 treated subjects (8%) and 0 of 13 control subjects had hearing impairment, as did 1 nonrandomized subject. Total seizure burden varied widely, with much higher seizure burden in treatment versus control groups (median = 3.1 vs 1.2 min/h, p = 0.006). There was significantly greater reduction in seizure burden 0 to 4 hours and 2 to 4 hours post-SDA (both p < 0.01) compared with 2-hour baseline in treatment versus control groups with adjustment for seizure burden.InterpretationAlthough definitive proof of efficacy awaits an appropriately powered phase 3 trial, this randomized, controlled, multicenter trial demonstrated an additional reduction in seizure burden attributable to bumetanide over phenobarbital without increased serious adverse effects. Future trials of bumetanide and other drugs should include a control group and balance seizure severity. ANN NEUROL 2021;89:327-340.

Dataset Information

Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial.

Publications

Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial.

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