Trial · NCT03367156

Dexamethasone in Controlling Dyspnea in Patients With Cancer

NCT03367156, Phase 2, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2022-12-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dexamethasone in Controlling Dyspnea in Patients With Cancer. Trials, record NCT03367156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03367156

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dexamethasone in Controlling Dyspnea in Patients With Cancer
NCT number: NCT03367156
Status: Active not recruiting
Phases: Phase 2
Enrollment: 135 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Dyspnea, Malignant Neoplasm
Interventions: Dexamethasone, Placebo, Questionnaire Administration
First posted: 2017-12-08
Last updated: 2026-10-16
Results first posted: 2022-12-21

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity	Baseline and Day 7	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.
Secondary	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity	Baseline and Day 14	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.
Secondary	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness	Baseline and Day 7	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.
Secondary	Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7	Baseline and Day 7	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.
Secondary	Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7	Baseline and Day 7	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.
Secondary	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness	Baseline and Day 14	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.
Secondary	Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14	Baseline and Day 14	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.
Secondary	Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14	Baseline and Day 14	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity	Baseline and Day 7	The Dyspnea Average Intensity Numeric score was missing for 4 participants in the Dexamethasone Arm and 1 participant in the Placebo Arm.	score on a scale	MEAN
SECONDARY	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity	Baseline and Day 14	Participants who were on the study at day 14 and received assessment.	score on a scale	MEAN
SECONDARY	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness	Baseline and Day 7	The Dyspnea Average Unpleasantness Numeric score was missing for 4 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.	score on a scale	MEAN
SECONDARY	Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7	Baseline and Day 7	The ESAS Dyspnea Numeric score was missing for 3 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.	score on a scale	MEDIAN
SECONDARY	Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7	Baseline and Day 7	The EORTC QLQ-C30 Dyspnea score was missing for 4 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm.	score on a scale	MEDIAN
SECONDARY	Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness	Baseline and Day 14	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.	score on a scale	MEDIAN
SECONDARY	Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14	Baseline and Day 14	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.	score on a scale	MEDIAN
SECONDARY	Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14	Baseline and Day 14	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.	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity	Dexamethasone	-1.6	95% Confidence Interval -2.0 to -1.2	score on a scale
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity	Placebo	-1.6	95% Confidence Interval -2.3 to -0.9	score on a scale
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity	Dexamethasone	-1.8	95% Confidence Interval -2.2 to -1.3	score on a scale
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity	Placebo	-1.9	95% Confidence Interval -2.6 to -1.2	score on a scale
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness	Dexamethasone	-1.8	95% Confidence Interval -2.3 to -1.2	score on a scale
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness	Placebo	-2.2	95% Confidence Interval -3.2 to -1.2	score on a scale
Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7	Dexamethasone	-1	Inter-Quartile Range -3 to -1	score on a scale
Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7	Placebo	-1.5	Inter-Quartile Range -3 to 0	score on a scale
Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7	Dexamethasone	-33.3	Inter-Quartile Range -33.3 to 0	score on a scale
Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7	Placebo	-33.3	Inter-Quartile Range -33.3 to 0	score on a scale

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dexamethasone	85
Overall Study	STARTED	Placebo	43
Overall Study	Completed 7 Days	Dexamethasone	76
Overall Study	Completed 7 Days	Placebo	38
Overall Study	Completed 14 Days	Dexamethasone	61
Overall Study	Completed 14 Days	Placebo	35
Overall Study	COMPLETED	Dexamethasone	61
Overall Study	COMPLETED	Placebo	35
Overall Study	NOT COMPLETED	Dexamethasone	24
Overall Study	NOT COMPLETED	Placebo	8

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Insomnia	Nervous system disorders	Dexamethasone	7	85
other	Insomnia	Nervous system disorders	Placebo	1	43
other	Pain	Nervous system disorders	Dexamethasone	2	85
other	Pain	Nervous system disorders	Placebo	1	43
other	Neuropsychiatric symptoms	Nervous system disorders	Dexamethasone	3	85
other	Neuropsychiatric symptoms	Nervous system disorders	Placebo	0	43
other	Dyspepsia	Gastrointestinal disorders	Dexamethasone	2	85
other	Dyspepsia	Gastrointestinal disorders	Placebo	0	43
other	Infection	General disorders	Dexamethasone	9	85
other	Infection	General disorders	Placebo	3	43

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dexamethasone	2	85
Total, all-cause mortality	Placebo	0	43
Total, other adverse events	Dexamethasone	32	85
Total, other adverse events	Placebo	7	43
Total, serious adverse events	Dexamethasone	24	85
Total, serious adverse events	Placebo	3	43

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36087590	DERIVED	PubMed
42018190	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
P30CA016672	The University of Texas MD Anderson Cancer Center Support Grant (CCSG)	KOONG, ALBERT	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1985 to 2026	NIH RePORTER
R01CA214960	A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients	HUI, DAVID	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	2017 to 2020	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dexamethasone vs Placebo: deaths from any cause	Trial comparisons
Dexamethasone vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03367156

GET https://conductscience.org/api/trials/v1/NCT03367156/events?page=2

API reference For AI assistants