Trial Outcomes & Findings for Dexamethasone in Controlling Dyspnea in Patients With Cancer (NCT NCT03367156)
NCT ID: NCT03367156
Last Updated: 2025-11-12
Results Overview
The average dyspnea intensity over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea scores between Baseline and Day 7 were measured. Linear model analysis was used for analysis.
ACTIVE_NOT_RECRUITING
PHASE2
135 participants
Baseline and Day 7
2025-11-12
Participant Flow
Ambulatory patients with cancer age ≥18, average dyspnea intensity over the past week ≥4/10 in a 0-10 point numeric rating scale, Karnofsky performance status ≥30% and ability to communicate in English or Spanish were selected from MD Anderson Cancer Center and Lyndon B. Johnson General Hospital, Houston, Texas, United States.
A total of 135 participants were enrolled but 128 were randomized. 7 participants were not randomized for various reasons.
Participant milestones
| Measure |
Dexamethasone
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Placebo
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
43
|
|
Overall Study
Completed 7 Days
|
76
|
38
|
|
Overall Study
Completed 14 Days
|
61
|
35
|
|
Overall Study
COMPLETED
|
61
|
35
|
|
Overall Study
NOT COMPLETED
|
24
|
8
|
Reasons for withdrawal
| Measure |
Dexamethasone
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Placebo
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Overall Study
Lack of interest
|
3
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Became ineligible
|
1
|
2
|
|
Overall Study
Hospitalization
|
1
|
0
|
|
Overall Study
Concerned about Treatment
|
11
|
3
|
|
Overall Study
Started new treatment
|
4
|
1
|
Baseline Characteristics
Dexamethasone in Controlling Dyspnea in Patients With Cancer
Baseline characteristics by cohort
| Measure |
Placebo
n=43 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Total
n=128 Participants
Total of all reporting groups
|
Dexamethasone
n=85 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
0 Participants
n=171 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
0 Participants
n=171 Participants
|
|
Age, Continuous
|
63 years
n=23 Participants
|
65 years
n=306 Participants
|
66 years
n=171 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=23 Participants
|
74 Participants
n=306 Participants
|
50 Participants
n=171 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=23 Participants
|
54 Participants
n=306 Participants
|
35 Participants
n=171 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=23 Participants
|
21 Participants
n=306 Participants
|
11 Participants
n=171 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=23 Participants
|
107 Participants
n=306 Participants
|
74 Participants
n=171 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
0 Participants
n=171 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
0 Participants
n=171 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=23 Participants
|
20 Participants
n=306 Participants
|
11 Participants
n=171 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=23 Participants
|
105 Participants
n=306 Participants
|
71 Participants
n=171 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
0 Participants
n=171 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
3 Participants
n=306 Participants
|
3 Participants
n=171 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=23 Participants
|
128 participants
n=306 Participants
|
85 participants
n=171 Participants
|
|
Cancer Stage
Stage I-II
|
15 Participants
n=23 Participants
|
33 Participants
n=306 Participants
|
18 Participants
n=171 Participants
|
|
Cancer Stage
Stage III
|
4 Participants
n=23 Participants
|
21 Participants
n=306 Participants
|
17 Participants
n=171 Participants
|
|
Cancer Stage
Stage IV
|
24 Participants
n=23 Participants
|
74 Participants
n=306 Participants
|
50 Participants
n=171 Participants
|
|
Cancer Type
Breast
|
2 Participants
n=23 Participants
|
7 Participants
n=306 Participants
|
5 Participants
n=171 Participants
|
|
Cancer Type
Gastrointestinal
|
7 Participants
n=23 Participants
|
13 Participants
n=306 Participants
|
6 Participants
n=171 Participants
|
|
Cancer Type
Genitourinary
|
4 Participants
n=23 Participants
|
6 Participants
n=306 Participants
|
2 Participants
n=171 Participants
|
|
Cancer Type
Respiratory
|
27 Participants
n=23 Participants
|
92 Participants
n=306 Participants
|
65 Participants
n=171 Participants
|
|
Cancer Type
Other
|
3 Participants
n=23 Participants
|
10 Participants
n=306 Participants
|
7 Participants
n=171 Participants
|
|
Comorbidity
COPD
|
12 Participants
n=23 Participants
|
44 Participants
n=306 Participants
|
32 Participants
n=171 Participants
|
|
Comorbidity
Asthma
|
5 Participants
n=23 Participants
|
11 Participants
n=306 Participants
|
6 Participants
n=171 Participants
|
|
Comorbidity
Bronchiectasis
|
1 Participants
n=23 Participants
|
2 Participants
n=306 Participants
|
1 Participants
n=171 Participants
|
|
Comorbidity
Heart Failure
|
3 Participants
n=23 Participants
|
8 Participants
n=306 Participants
|
5 Participants
n=171 Participants
|
|
Comorbidity
Pulmonary Embolism
|
1 Participants
n=23 Participants
|
3 Participants
n=306 Participants
|
2 Participants
n=171 Participants
|
|
Comorbidity
Other
|
1 Participants
n=23 Participants
|
6 Participants
n=306 Participants
|
5 Participants
n=171 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 7Population: The Dyspnea Average Intensity Numeric score was missing for 4 participants in the Dexamethasone Arm and 1 participant in the Placebo Arm.
The average dyspnea intensity over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea scores between Baseline and Day 7 were measured. Linear model analysis was used for analysis.
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Dexamethasone
n=72 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity
|
-1.6 score on a scale
Interval -2.3 to -0.9
|
-1.6 score on a scale
Interval -2.0 to -1.2
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: Participants who were on the study at day 14 and received assessment.
The average dyspnea intensity over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea scores between Baseline and Day 14 were measured. Linear model analysis was used for analysis.
Outcome measures
| Measure |
Placebo
n=35 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Dexamethasone
n=68 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity
|
-1.9 score on a scale
Interval -2.6 to -1.2
|
-1.8 score on a scale
Interval -2.2 to -1.3
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: The Dyspnea Average Unpleasantness Numeric score was missing for 4 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.
The average dyspnea unpleasantness over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea unpleasantness scores between Baseline and Day 7 were measured. Linear model analysis was used for analysis.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Dexamethasone
n=72 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness
|
-2.2 score on a scale
Interval -3.2 to -1.2
|
-1.8 score on a scale
Interval -2.3 to -1.2
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: The ESAS Dyspnea Numeric score was missing for 3 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.
ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of well being. The change in ESAS fatigue score between Baseline and Day 7 were measured. Total ESAS fatigue score ranged from 0-10, with a higher score indicating higher fatigue. Linear model analysis was used for analysis.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Dexamethasone
n=73 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7
|
-1.5 score on a scale
Interval -3.0 to 0.0
|
-1 score on a scale
Interval -3.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: The EORTC QLQ-C30 Dyspnea score was missing for 4 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated quality-of-life assessment for patients with cancer, consisting of 30 questions that encompass three symptom scales (pain, fatigue, and nausea/vomiting) and six questions about single symptoms, as well as five functional scales (physical, cognitive, role, emotional, and social) and one scale assessing global health status/quality of life. Each single symptoms have four response categories (1=not at all, and 4=very much). The change in EORTC fatigue score between Baseline and Day 7 were measured. Total scores using a complex scoring procedures ranges from 0 to 100 with a higher scores indicating higher fatigue. Linear model analysis was used for analysis.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Dexamethasone
n=72 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7
|
-33.3 score on a scale
Interval -33.3 to 0.0
|
-33.3 score on a scale
Interval -33.3 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: The Dyspnea Average Unpleasantness score was missing for 1 participant in the Placebo Arm. Participants who were on the study at day 14 and received assessment in the Dexamethasone Arm.
The average dyspnea unpleasantness over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea unpleasantness scores between Baseline and Day 14 were measured. Linear model analysis was used for analysis.
Outcome measures
| Measure |
Placebo
n=34 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Dexamethasone
n=68 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness
|
-2.3 score on a scale
Interval -3.4 to -1.3
|
-1.7 score on a scale
Interval -2.4 to -1.1
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: The ESAS Dyspnea score was missing for 3 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm. Participants who were on the study at day 14 and received assessment in the Dexamethasone Arm.
ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of well being. The change in ESAS fatigue score between Baseline and Day 14 were measured. Total ESAS fatigue score ranged from 0-10, with a higher score indicating higher fatigue. Linear model analysis was used for analysis.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Dexamethasone
n=65 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14
|
-1 score on a scale
Interval -4.0 to 0.0
|
-2 score on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: The EORTC Dyspnea score was missing for 2 participants in the Dexamethasone Arm and 3 participant in the Placebo Arm. Participants who were on the study at day 14 and received assessment in the Dexamethasone Arm.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated quality-of-life assessment for patients with cancer, consisting of 30 questions that encompass three symptom scales (pain, fatigue, and nausea/vomiting) and six questions about single symptoms, as well as five functional scales (physical, cognitive, role, emotional, and social) and one scale assessing global health status/quality of life. Each single symptoms have four response categories (1=not at all, and 4=very much). The change in EORTC fatigue score between Baseline and Day 14 were measured. Total scores using a complex scoring procedures ranges from 0 to 100 with a higher scores indicating higher fatigue. Linear model analysis was used for analysis.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Dexamethasone
n=66 Participants
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14
|
-33.3 score on a scale
Interval -33.3 to 0.0
|
-33.3 score on a scale
Interval -33.3 to 0.0
|
Adverse Events
Dexamethasone
Placebo
Serious adverse events
| Measure |
Dexamethasone
n=85 participants at risk
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Placebo
n=43 participants at risk
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
2/85 • Day 0 to Day 14
|
2.3%
1/43 • Day 0 to Day 14
|
|
Cardiac disorders
Cardiac Arrest
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Renal and urinary disorders
Catheter related infection
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Psychiatric disorders
Confusion
|
2.4%
2/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Gastrointestinal disorders
Dehydration
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Psychiatric disorders
Depression
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
8.2%
7/85 • Day 0 to Day 14
|
4.7%
2/43 • Day 0 to Day 14
|
|
Cardiac disorders
Myocardial Infarction
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Psychiatric disorders
Pyschosis
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
2.4%
2/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Cardiac disorders
Thromboembolic Event
|
2.4%
2/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
1.2%
1/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
Other adverse events
| Measure |
Dexamethasone
n=85 participants at risk
Participants were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
Placebo
n=43 participants at risk
Placebo capsules were given 2 capsules (4mg each) by mouth twice daily (day1-day7), then 1 capsule twice daily for the next 7 days (day 8-day 14).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
2.4%
2/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Cardiac disorders
Myocardial Infarction
|
1.2%
1/85 • Day 0 to Day 14
|
2.3%
1/43 • Day 0 to Day 14
|
|
Nervous system disorders
Insomnia
|
8.2%
7/85 • Day 0 to Day 14
|
2.3%
1/43 • Day 0 to Day 14
|
|
Nervous system disorders
Pain
|
2.4%
2/85 • Day 0 to Day 14
|
2.3%
1/43 • Day 0 to Day 14
|
|
Nervous system disorders
Neuropsychiatric symptoms
|
3.5%
3/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
2/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
General disorders
Infection
|
10.6%
9/85 • Day 0 to Day 14
|
7.0%
3/43 • Day 0 to Day 14
|
|
General disorders
Fatigue
|
3.5%
3/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Cardiac disorders
Hypertension
|
2.4%
2/85 • Day 0 to Day 14
|
0.00%
0/43 • Day 0 to Day 14
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/85 • Day 0 to Day 14
|
2.3%
1/43 • Day 0 to Day 14
|
Additional Information
Dr. David Hui- Professor, Palliative Care Medicine
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place