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Corticosteroid

Dexamethasone for Cancer-Related Shortness of Breath

Phase 2
Waitlist Available
Led By David Hui
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status >= 30%
Dyspnea with an average intensity >= 4 on the dyspnea NRS (range 0-10) over the past week.
Must not have
Delirium (i.e., score > 13 on the Memorial Delirium Assessment Scale; range 1-30)
Diagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 14

Summary

This trial study is testing whether dexamethasone can help control dyspnea and improve quality of life in cancer patients.

Who is the study for?
This trial is for cancer patients experiencing significant shortness of breath, who are treated at MD Anderson Cancer Center or LBJ Hospital. They must not be on long-term steroids, have uncontrolled diabetes, infections needing antibiotics, recent major surgery, severe anxiety or certain other health issues.
What is being tested?
The study tests if dexamethasone can help control shortness of breath in cancer patients compared to a placebo. Participants will also fill out questionnaires about their symptoms and quality of life.
What are the potential side effects?
Dexamethasone may cause side effects like increased blood sugar levels (especially important for diabetics), lowered immunity making you more prone to infections, mood swings, insomnia and possibly worsening any existing infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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I have had significant shortness of breath, averaging 4 or more out of 10, over the last week.
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I have been diagnosed with cancer.
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I have had significant shortness of breath in the past week.
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I can communicate in English or Spanish.
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My scans suggest cancer may be in my chest area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with delirium.
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My diabetes is not controlled by pills or insulin.
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I have a surgical wound that has not yet healed.
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I am not on antibiotics for an infection right now.
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I will start chemotherapy or immunotherapy soon and cannot take dexamethasone with it.
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I am currently experiencing a worsening of my COPD symptoms.
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I am experiencing worsening heart failure currently.
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I have been using corticosteroids for more than 14 days.
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I will not use higher doses of corticosteroids than those in this study.
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I have not had major surgery in the last 2 weeks.
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I am currently taking Megestrol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity
Secondary study objectives
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness
+4 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (dexamethasone)Experimental Treatment2 Interventions
Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.
Group II: Group II (placebo, dexamethasone)Active Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,068 Previous Clinical Trials
1,802,544 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,004 Total Patients Enrolled
David HuiPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,806 Total Patients Enrolled

Media Library

Shortness of Breath Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT03367156 — Phase 2
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03367156 — Phase 2
~17 spots leftby Nov 2025
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