Dexamethasone in Controlling Dyspnea in Patients With Cancer
NCT ID: NCT03367156
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
135 participants
INTERVENTIONAL
2017-12-04
2025-12-31
Brief Summary
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Detailed Description
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I. Compare the intensity of dyspnea (numeric rating scale \[NRS\]) in the dexamethasone arm with that in the placebo arm at week 1.
SECONDARY OBJECTIVES:
I. Compare the effects of dexamethasone with those of placebo in terms of personalized dyspnea response (based on a personalized dyspnea goal), unpleasantness of dyspnea, other symptoms, health-related quality of life, respiratory physiologic function, and adverse effects at week 1 and week 2, as well as the intensity of dyspnea at week 2.
II. Identify predictive markers of dyspnea response to dexamethasone.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive dexamethasone orally (PO) twice daily (BID) on days 1-28 in the absence of disease progression or unacceptable toxicity.
GROUP II: 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.
After completion of study treatment, patients are followed up at days 28 and 42.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group I (dexamethasone)
Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.
Dexamethasone
Given PO
Questionnaire Administration
Ancillary studies
Group II (placebo, dexamethasone)
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.
Dexamethasone
Given PO
Placebo
Given PO
Questionnaire Administration
Ancillary studies
Interventions
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Dexamethasone
Given PO
Placebo
Given PO
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Hui
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Lyndon B. Johnson Hospital
Houston, Texas, United States
Harris Health System Settegast Health Center
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-01129
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0591
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0591
Identifier Type: -
Identifier Source: org_study_id