Dexamethasone in Controlling Dyspnea in Patients With Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
- Compare the intensity of dyspnea (numeric rating scale [NRS]) in the dexamethasone arm with that in the placebo arm at week 1.
SECONDARY OBJECTIVES:
-
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.
-
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I (dexamethasone) Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. |
Drug: Dexamethasone
Given PO
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Active Comparator: 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. |
Drug: Dexamethasone
Given PO
Other Names:
Other: Placebo
Given PO
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Dyspnea numeric rating scale (NRS) score [At day 7]
Primary analysis will be a linear model comparing mean day 7 scores between treatment groups while adjusting for baseline levels. The data will be graphed and residual analyses will be performed to verify assumptions of the model and take appropriate actions if the assumptions appear to be validated (e.g., transforming the data). Data will be analyzed with modified intention-to-treat analysis, by including all participants who were randomized started the study treatment, regardless of whether they complete the study. Multiple imputation to handle missing data for the primary outcome will be measured. Sensitivity analyses with worst case scenario (assume no change if no primary outcome data) and last value carry forward approaches will also be developed.
Secondary Outcome Measures
- Forced expiratory volume in one second (FEV1) [At day 7 and 14]
Linear model analyses will be performed.
- Forced vital capacity (FVC) [At day 7 and 14]
Linear model analyses will be performed.
- Maximal inspiratory pressure (MIP) [At day 7 and 14]
Linear model analyses will be performed.
- Oxygen saturation [At day 7 and 14]
Linear model analyses will be performed.
- Edmonton Symptom Assessment Scale (ESAS) [At day 7 and 14]
Linear model analyses will be performed.
- Hospital Anxiety and Depression Scale (HADS) [At day 7 and 14]
Linear model analyses will be performed.
- European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) [At day 7 and 14]
Linear model analyses will be performed.
- Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) frequency/severity/interference [At day 7 and 14]
For clinician-rated CTCAE adverse effects, grade, type, attribution, and treatment group will be tabulated and will compare the incidence of grade 3 or higher treatment-related toxic effects between treatment groups using logistic regression. For the daily dyspnea NRS values, linear mixed-effects models will be used to compare changes in scores over time between treatment groups (for the first 7 days and for the first 14 days).
- Difference in dyspnea NRS [Baseline to day 7]
> 1.0 is considered clinically significant. Logistic regression analysis will be used to identify independent predictors of this outcome, including baseline dyspnea NRS, restrictive or obstructive lung disease pattern, MIP, sex, and baseline inflammatory cytokine levels (IL-1a, IL-6, IL-8, IL-10, and TNF-a). The data will be plotted and residual analyses will be used to verify assumptions of the model and take appropriate actions if they appear to be validated (e.g., transforming the data). The variance inflation factor will be used to identify collinearity.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of cancer.
-
Dyspnea with an average intensity >= 4 on the dyspnea NRS (range 0-10) over the past week.
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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.
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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).
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Oxygen saturation < 90% despite supplemental oxygen > 6 L/minute.
-
Previous allergic reactions to dexamethasone.
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Diagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin.
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Postsurgical open wound that has not healed at the time of enrollment.
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Any infection requiring antibiotics at the time of study enrollment.
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Major surgery within the past 2 weeks.
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Megestrol use at the time of study enrollment.
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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).
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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.
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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).
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Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study enrollment.
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Heart failure exacerbation at the time of study enrollment.
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Expected to undergo therapeutic thoracentesis in the next 2 weeks.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lyndon B. Johnson Hospital | Houston | Texas | United States | 77026 |
| 2 | Harris Health System Settegast Health Center | Houston | Texas | United States | 77028 |
| 3 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: David Hui, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2017-0591
- NCI-2018-01129
- 2017-0591