drugset / Trial / NCT03367156
Dexamethasone in Controlling Dyspnea in Patients With Cancer
Phase 2
Active not recruiting
135 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindSupportive care
Summary
This phase II trial studies how well dexamethasone works in controlling dyspnea in patients with cancer. Dexamethasone may help control dyspnea (shortness of breath) and improve lung function and quality of life in cancer patients.
Timeline
- Start
- 2017-12-04
- Primary completion
- 2021-05-05
- Completion
- 2028-12-31
Outcome
Missed primary endpoint
registry analysis (other test); Dexamethasone vs Placebo; p = 0.48; Mean Difference (Final Values) 0 (95% CI -0.8 to 0.7); Linear Model NCT03367156 ↗
paper High-dose dexamethasone did not improve dyspnoea in patients with cancer more effectively than placebo PMID 36087590 ↗
Publications
- Hui D, Jennings K, Ontai A, Hanneman SK, Bruera E. Predictive biomarkers of placebo response in patients with cancer: an exploratory analysis of the ABCD randomized clinical trial. Support Care Cancer. 2026 Apr 22;34(5):452. doi: 10.1007/s00520-026-10689-9.
- Hui D, Puac V, Shelal Z, Dev R, Hanneman SK, Jennings K, Ma H, Urbauer DL, Shete S, Fossella F, Liao Z, Blumenschein G Jr, Chang JY, O'Reilly M, Gandhi SJ, Tsao A, Mahler DA, Bruera E. Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial. Lancet Oncol. 2022 Oct;23(10):1321-1331. doi: 10.1016/S1470-2045(22)00508-3. Epub 2022 Sep 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 4 mg | Oral |