Phase 2 N=41 Randomized Double-blind Treatment

Dexamethasone Dyspnea Study

Advanced Cancers · Hematologic Disorder · Solid Tumors

Bottom Line

View on ClinicalTrials.gov: NCT01670097 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Number of Participants Who Completed the Dyspnea Numeric Rating Scale — 18; 17 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dexamethasone (Drug); Placebo (Drug); Questionnaires (Behavioral); Spirometer (Device); Phone Calls (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Completed the Dyspnea Numeric Rating Scale	18; 17	—
SECONDARY Edmonton Symptom Assessment System Dyspnea Score	-1.9; -0.7; -1.8; -1.3; -2.1; -1.7	—
SECONDARY Dyspnea Numeric Rating Score (Now)	0; -0.1; -1.1; -0.2; -1.6; -1.5	—
SECONDARY European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea	-15.6; 0; -10.4; -5.1; -7.7; -6.7	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Diagnosis of cancer
Dyspnea with an average intensity level >3/10 on the numeric rating scale over the past week
Clinical or radiologic history of lung/pleural involvement (primary or metastatic), lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration
Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation Service, Thoracic Oncology or Pulmonary Medicine
Able to communicate in English
Karnofsky performance status >=40%
Age 18 or older
Permission from the attending medical oncologist if the patient is currently on an interventional cancer therapy trial.

Exclusion Criteria

Delirium (i.e. Memorial delirium rating scale >13)
Oxygen saturation 6L/min
Previous allergic reactions to dexamethasone
Uncontrolled hyperglycemia as defined by any blood glucose of >300 mg/dl in the past two weeks
Severe anemia (Hb 14 days) at the time of study enrollment
Unwilling to provide informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01670097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.