Clinical trial · Interventional
Dexamethasone in Controlling Dyspnea in Patients With Cancer
A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients
NCT03367156CI-TRIAL-00114443active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyspnea | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Placebo | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (dexamethasone)
- description
- Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Dexamethasone
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Group II (placebo, dexamethasone)
- description
- Patients receive placebo PO BID on days 1-14 and dexamethasone PO BID on days 15-28 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Dexamethasone
- Other: Placebo
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of cancer. * Dyspnea with an average intensity \>= 4 on the dyspnea NRS (range 0-10) over the past week. * Radiologic suspicion of thoracic involvement, such as primary or metastatic lung cancer, lymphangitic carcinomatosis, airway infiltration, lymphadenopathy, pleural or chest wall invasion. * Seen at an outpatient clinic at MD Anderson Cancer Center or Lyndon B. Johnson (LBJ) Hospital General Oncology Clinic. * Able to communicate in English or Spanish. * Karnofsky performance status \>= 30%. Exclusion Criteria: * Delirium (i.e., score \> 13 on the Memorial Delirium Assessment Scale; range 1-30). * Oxygen saturation \< 90% despite supplemental oxygen \> 6 L/minute. * Previous allergic reactions to dexamethasone. * Diagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin. * Postsurgical open wound that has not healed at the time of enrollment. * Any infection requiring antibiotics at the time of study enrollment. * Major surgery within the past 2 weeks. * Megestrol use at the time of study enrollment. * Neutropenia (absolute neutrophil count \< 1.0 x 10\^9/L) at the time of study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks). * Currently receiving or expected to start cytotoxic chemotherapy or immunotherapy within 1 week of study enrollment and additional dexamethasone cannot be used concurrently as per attending oncologist. * Severe anemia (hemoglobin \< 8 g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks). * Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment. * Heart failure exacerbation at the time of study enrollment. * Expected to undergo therapeutic thoracentesis in the next 2 weeks. * High anxiety score (\>= 15/21) on the Hospital Anxiety and Depression Scale (HADS). * Chronic systemic corticosteroid use (\> 14 days) at the time of study enrollment. * Any expected corticosteroid use during study enrollment at higher doses than will be used in this study.
References
Publications (2)
- DERIVEDHui 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. PMID 42018190
- DERIVEDHui 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. PMID 36087590