Dexamethasone in Controlling Dyspnea in Patients With Cancer

• ClinicalTrials.gov Identifier: NCT03367156
• Recruitment Status: Active, not recruiting
• First Posted: December 8, 2017
• Results First Posted: December 21, 2022
• Last Update Posted: December 21, 2022
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Conditions: Dyspnea; Malignant Neoplasm
• Interventions: Drug: Dexamethasone; Other: Placebo; Other: Questionnaire Administration
• Enrollment: 135

Participant Flow

Recruitment Details	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.
Pre-assignment Details	A total of 135 participants were enrolled but 128 were randomized. 7 participants were not randomized for various reasons.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description	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 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).
Period Title: Overall Study
Started	85	43
Completed 7 Days	76	38
Completed 14 Days	61	35
Completed	61	35
Not Completed	24	8
Reason Not Completed
Lack of interest	3	1
Death	2	0
Lost to Follow-up	2	1
Became ineligible	1	2
Hospitalization	1	0
Concerned about Treatment	11	3
Started new treatment	4	1

Baseline Characteristics

Arm/Group Title		Dexamethasone	Placebo	Total
Arm/Group Description		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 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 of all reporting groups
Overall Number of Baseline Participants		85	43	128
Baseline Analysis Population Description		All randomized participants
Age, Continuous; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	85 participants	43 participants	128 participants
		66; (61 to 73)	63; (57 to 71)	65; (60 to 73)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	85 participants	43 participants	128 participants
	Female	50 58.8%	24 55.8%	74 57.8%
	Male	35 41.2%	19 44.2%	54 42.2%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	85 participants	43 participants	128 participants
	Hispanic or Latino	11 12.9%	10 23.3%	21 16.4%
	Not Hispanic or Latino	74 87.1%	33 76.7%	107 83.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	85 participants	43 participants	128 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	11 12.9%	9 20.9%	20 15.6%
	White	71 83.5%	34 79.1%	105 82.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	3 3.5%	0 0.0%	3 2.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	85 participants	43 participants	128 participants
		85	43	128
Cancer Stage [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	85 participants	43 participants	128 participants
	Stage I-II	18 21.2%	15 34.9%	33 25.8%
	Stage III	17 20.0%	4 9.3%	21 16.4%
	Stage IV	50 58.8%	24 55.8%	74 57.8%
		[1] Measure Description: Stage IV has the worst outcome.
Cancer Type; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	85 participants	43 participants	128 participants
	Breast	5 5.9%	2 4.7%	7 5.5%
	Gastrointestinal	6 7.1%	7 16.3%	13 10.2%
	Genitourinary	2 2.4%	4 9.3%	6 4.7%
	Respiratory	65 76.5%	27 62.8%	92 71.9%
	Other	7 8.2%	3 7.0%	10 7.8%
Comorbidity; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	85 participants	43 participants	128 participants
COPD		32 37.6%	12 27.9%	44 34.4%
Asthma		6 7.1%	5 11.6%	11 8.6%
Bronchiectasis		1 1.2%	1 2.3%	2 1.6%
Heart Failure		5 5.9%	3 7.0%	8 6.3%
Pulmonary Embolism		2 2.4%	1 2.3%	3 2.3%
Other		5 5.9%	1 2.3%	6 4.7%

Outcome Measures

1. Primary Outcome

Title	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity
Description	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.
Time Frame	Baseline and Day 7

Outcome Measure Data

Analysis Population Description

The Dyspnea Average Intensity Numeric score was missing for 4 participants in the Dexamethasone Arm and 1 participant in the Placebo Arm.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description:	Participants were given 2capsules (4mg each) twice daily (Day1-Day7), then 1 capsule twice daily for the next 7 days (Day 8-Day14).	Participants were given 2capsules (4mg each) twice daily (Day1-Day7), then 1 capsule twice daily for the next 7 days (Day 8-Day14).
Overall Number of Participants Analyzed	72	37
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-1.6; (-2.0 to -1.2)	-1.6; (-2.3 to -0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.48
	Comments	[Not Specified]
	Method	Linear Model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -0.8 to 0.7
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity
Description	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.
Time Frame	Baseline and Day 14

Outcome Measure Data

Analysis Population Description

Participants who were on the study at day 14 and received assessment.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	68	35
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-1.8; (-2.2 to -1.3)	-1.9; (-2.6 to -1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.99
	Comments	[Not Specified]
	Method	Linear Model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -0.7 to 1
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness
Description	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.
Time Frame	Baseline and Day 7

Outcome Measure Data

Analysis Population Description

The Dyspnea Average Unpleasantness Numeric score was missing for 4 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	72	36
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-1.8; (-2.3 to -1.2)	-2.2; (-3.2 to -1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.97
	Comments	[Not Specified]
	Method	Linear Model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -0.7 to 1.6
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7
Description	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.
Time Frame	Baseline and Day 7

Outcome Measure Data

Analysis Population Description

The ESAS Dyspnea Numeric score was missing for 3 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	73	36
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	-1; (-3 to -1)	-1.5; (-3 to 0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.78
	Comments	[Not Specified]
	Method	Linear Model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.8 to 1.0
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7
Description	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.
Time Frame	Baseline and Day 7

Outcome Measure Data

Analysis Population Description

The EORTC QLQ-C30 Dyspnea score was missing for 4 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	72	36
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	-33.3; (-33.3 to 0)	-33.3; (-33.3 to 0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.93
	Comments	[Not Specified]
	Method	Linear Model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -10.6 to 9.6
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness
Description	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.
Time Frame	Baseline and Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	68	34
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	-1.7; (-2.4 to -1.1)	-2.3; (-3.4 to -1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.93
	Comments	[Not Specified]
	Method	Linear Model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; -0.6 to 1.8
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14
Description	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.
Time Frame	Baseline and Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	65	33
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	-2; (-3 to 0)	-1; (-4 to 0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.82
	Comments	[Not Specified]
	Method	Linear Model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.9 to 1.1
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14
Description	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.
Time Frame	Baseline and Day 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	66	32
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	-33.3; (-33.3 to 0)	-33.3; (-33.3 to 0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.38
	Comments	[Not Specified]
	Method	Linear Model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.5
	Confidence Interval	(2-Sided) 95%; -17.9 to 6.9
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Day 0 to Day 14
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Dexamethasone	Placebo
Arm/Group Description	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 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).
All-Cause Mortality
	Dexamethasone	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/85 (2.35%)	0/43 (0.00%)
Serious Adverse Events
	Dexamethasone	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	24/85 (28.24%)	3/43 (6.98%)
Cardiac disorders
Cardiac Arrest † 1	1/85 (1.18%)	0/43 (0.00%)
Myocardial Infarction † 1	1/85 (1.18%)	0/43 (0.00%)
Thromboembolic Event † 1	2/85 (2.35%)	0/43 (0.00%)
Gastrointestinal disorders
Abdominal pain † 1	2/85 (2.35%)	1/43 (2.33%)
Dehydration † 1	1/85 (1.18%)	0/43 (0.00%)
Nausea † 1	1/85 (1.18%)	0/43 (0.00%)
Musculoskeletal and connective tissue disorders
Fracture † 1	1/85 (1.18%)	0/43 (0.00%)
Weakness † 1	1/85 (1.18%)	0/43 (0.00%)
Psychiatric disorders
Confusion † 1	2/85 (2.35%)	0/43 (0.00%)
Depression † 1	1/85 (1.18%)	0/43 (0.00%)
Pyschosis † 1	1/85 (1.18%)	0/43 (0.00%)
Renal and urinary disorders
Catheter related infection † 1	1/85 (1.18%)	0/43 (0.00%)
Respiratory, thoracic and mediastinal disorders
Lung Infection † 1	7/85 (8.24%)	2/43 (4.65%)
Respiratory Distress † 1	2/85 (2.35%)	0/43 (0.00%)
1 Term from vocabulary, CTCAE (4.03); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Dexamethasone	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	32/85 (37.65%)	7/43 (16.28%)
Cardiac disorders
Hypertension † 1	2/85 (2.35%)	0/43 (0.00%)
Myocardial Infarction † 1	1/85 (1.18%)	1/43 (2.33%)
Gastrointestinal disorders
Dyspepsia † 1	2/85 (2.35%)	0/43 (0.00%)
Nausea † 1	1/85 (1.18%)	1/43 (2.33%)
General disorders
Infection † 1	9/85 (10.59%)	3/43 (6.98%)
Fatigue † 1	3/85 (3.53%)	0/43 (0.00%)
Nervous system disorders
Insomnia † 1	7/85 (8.24%)	1/43 (2.33%)
Pain † 1	2/85 (2.35%)	1/43 (2.33%)
Neuropsychiatric symptoms † 1	3/85 (3.53%)	0/43 (0.00%)
Respiratory, thoracic and mediastinal disorders
Respiratory Distress † 1	2/85 (2.35%)	0/43 (0.00%)
1 Term from vocabulary, CTCAE (4.03); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. David Hui- Professor, Palliative Care Medicine
• Organization: UT MD Anderson Cancer Center
• Phone: (713) 792-6258
• EMail: dhui@mdanderson.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT03367156
• Other Study ID Numbers: 2017-0591; NCI-2018-01129 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2017-0591 ( Other Identifier: M D Anderson Cancer Center )
• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Results First Submitted: September 22, 2022
• Results First Posted: December 21, 2022
• Last Update Posted: December 21, 2022