Clinical trial · Interventional
Dexamethasone Dyspnea Study
A Preliminary Study of Dexamethasone for Dyspnea in Cancer Patients
NCT01670097CI-TRIAL-00050099completedPhase 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)
The goal of this clinical research study is to learn if dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo. Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help patients with shortness of breath. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Hematologic Disorder | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Phone Calls | Other | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Spirometer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dexamethasone
- description
- Dexamethasone 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.
- interventionNames
- Drug: Dexamethasone
- Behavioral: Questionnaires
- Device: Spirometer
- Other: Phone Calls
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Two placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of cancer 2. Dyspnea with an average intensity level \>3/10 on the numeric rating scale over the past week 3. Clinical or radiologic history of lung/pleural involvement (primary or metastatic), lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration 4. Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation Service, Thoracic Oncology or Pulmonary Medicine 5. Able to communicate in English 6. Karnofsky performance status \>=40% 7. Age 18 or older 8. Permission from the attending medical oncologist if the patient is currently on an interventional cancer therapy trial. Exclusion Criteria: 1. Delirium (i.e. Memorial delirium rating scale \>13) 2. Oxygen saturation \<90% despite supplemental oxygen \>6L/min 3. Previous allergic reactions to dexamethasone 4. Uncontrolled hyperglycemia as defined by any blood glucose of \>300 mg/dl in the past two weeks 5. Severe anemia (Hb \<7g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks) 6. Post-surgical open wound that has not been healed at the time of enrollment 7. Any infection requiring parenteral antibiotics within the past 2 weeks 8. Major surgery within the past 2 weeks 9. Megestrol use at the time of study enrollment 10. Neutropenia (absolute neutrophil count \< 1.0) (bloodwork is not required if patient did not have recent chemotherapy within last 2 weeks) 11. Currently on or expected to start cytotoxic chemotherapy with in 1 week of study enrollment 12. Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment 13. Heart failure exacerbation at the time of study enrollment 14. Chronic systemic corticosteroid use (\>14 days) at the time of study enrollment 15. Unwilling to provide informed consent
References
Publications (1)
- DERIVEDHui D, Kilgore K, Frisbee-Hume S, Park M, Tsao A, Delgado Guay M, Lu C, William W Jr, Pisters K, Eapen G, Fossella F, Amin S, Bruera E. Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial. J Pain Symptom Manage. 2016 Jul;52(1):8-16.e1. doi: 10.1016/j.jpainsymman.2015.10.023. Epub 2016 Jun 18. PMID 27330023