Trial · NCT01670097
Dexamethasone Dyspnea Study
NCT01670097, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2021-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dexamethasone Dyspnea Study. Trials, record NCT01670097. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01670097
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexamethasone Dyspnea Study
- NCT number
- NCT01670097
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Advanced Cancers, Hematologic Disorder, Solid Tumors
- Interventions
- Dexamethasone, Placebo, Questionnaires, Spirometer, Phone Calls
- First posted
- 2012-08-21
- Last updated
- 2021-02-17
- Results first posted
- 2021-02-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Completed the Dyspnea Numeric Rating Scale | Baseline to Day 7 | Number of participants who completed the dyspnea numeric rating scale on Day 7 |
| Secondary | Edmonton Symptom Assessment System Dyspnea Score | Baseline to Day 4, Day 7, Day 14 | The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14. |
| Secondary | Dyspnea Numeric Rating Score (Now) | Baseline to day 4, Day 7 and Day 14 | Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14. |
| Secondary | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea | Baseline to day 4, Day 7 and Day 14. | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week ("Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Completed the Dyspnea Numeric Rating Scale | Baseline to Day 7 | Baseline Analysis included all randomized participants, 20 participants in intervention arm and 21 participants in control arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Edmonton Symptom Assessment System Dyspnea Score | Baseline to Day 4, Day 7, Day 14 | The number of participants varied by milestone study days (Baseline (38 participants) , Day 4 (30 participants) , Day 7 (30 participants) and Day 14 (28 participants) who completed the Edmonton Symptom Assessment Questionnaire. | score on a scale | MEAN |
| SECONDARY | Dyspnea Numeric Rating Score (Now) | Baseline to day 4, Day 7 and Day 14 | The number of participants varied by milestone study days (Baseline (38 participants), Day 4, (35 participants) Day 7 (35 participants), and Day 14 (26 participants) who completed the Dyspnea Numeric Rating Score Questionnaire. | score on a scale | MEAN |
| SECONDARY | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea | Baseline to day 4, Day 7 and Day 14. | The number of participants varied by milestone study days (Baseline (38 participants), Day 4 (30 participants), Day 7 (29 participants), and Day 14 (28 participants) who completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-20 Dyspnea. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Completed the Dyspnea Numeric Rating Scale | Intervention Group (Dexamethasone) | 18 | Participants | ||
| Number of Participants Who Completed the Dyspnea Numeric Rating Scale | Controlled Group (Placebo) | 17 | Participants | ||
| Edmonton Symptom Assessment System Dyspnea Score | Intervention Group (Dexamethasone) | Day 4 | -1.9 | 95% Confidence Interval -3.3 to -0.5 | score on a scale |
| Edmonton Symptom Assessment System Dyspnea Score | Controlled Group (Placebo) | Day 4 | -0.7 | 95% Confidence Interval -2.1 to 0.6 | score on a scale |
| Edmonton Symptom Assessment System Dyspnea Score | Intervention Group (Dexamethasone) | Day 7 | -1.8 | 95% Confidence Interval -3.2 to -0.3 | score on a scale |
| Edmonton Symptom Assessment System Dyspnea Score | Controlled Group (Placebo) | Day 7 | -1.3 | 95% Confidence Interval -2.4 to -0.2 | score on a scale |
| Edmonton Symptom Assessment System Dyspnea Score | Intervention Group (Dexamethasone) | Day 14 | -2.1 | 95% Confidence Interval -3.5 to -0.6 | score on a scale |
| Edmonton Symptom Assessment System Dyspnea Score | Controlled Group (Placebo) | Day 14 | -1.7 | 95% Confidence Interval -2.7 to -0.7 | score on a scale |
| Dyspnea Numeric Rating Score (Now) | Intervention Group (Dexamethasone) | Day 4 | 0 | 95% Confidence Interval -1 to 1 | score on a scale |
| Dyspnea Numeric Rating Score (Now) | Controlled Group (Placebo) | Day 4 | -0.1 | 95% Confidence Interval -1.1 to 1 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Group (Dexamethasone) | 20 | |
| Overall Study | STARTED | Controlled Group (Placebo) | 21 | |
| Overall Study | Completed Week 1 Intervention | Intervention Group (Dexamethasone) | 18 | |
| Overall Study | Completed Week 1 Intervention | Controlled Group (Placebo) | 17 | |
| Overall Study | Completed Week 2 Intervention | Intervention Group (Dexamethasone) | 13 | |
| Overall Study | Completed Week 2 Intervention | Controlled Group (Placebo) | 15 | |
| Overall Study | COMPLETED | Intervention Group (Dexamethasone) | 18 | |
| Overall Study | COMPLETED | Controlled Group (Placebo) | 17 | |
| Overall Study | NOT COMPLETED | Intervention Group (Dexamethasone) | 2 | |
| Overall Study | NOT COMPLETED | Controlled Group (Placebo) | 4 |
Source ClinicalTrials.gov
Adverse events44
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 | Events |
|---|---|---|---|---|---|---|
| other | Anxiety/Irritability | Nervous system disorders | Intervention Group (Dexamethasone) | 2 | 20 | |
| other | Anxiety/Irritability | Nervous system disorders | Controlled Group (Placebo) | 0 | 21 | |
| other | Diarrhea | Gastrointestinal disorders | Intervention Group (Dexamethasone) | 1 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | Controlled Group (Placebo) | 0 | 21 | |
| other | Dyspepsia | Gastrointestinal disorders | Intervention Group (Dexamethasone) | 1 | 20 | |
| other | Dyspepsia | Gastrointestinal disorders | Controlled Group (Placebo) | 2 | 21 | |
| other | Halitosis | Gastrointestinal disorders | Intervention Group (Dexamethasone) | 1 | 20 | |
| other | Halitosis | Gastrointestinal disorders | Controlled Group (Placebo) | 0 | 21 | |
| other | Edema | General disorders | Intervention Group (Dexamethasone) | 3 | 20 | |
| other | Edema | General disorders | Controlled Group (Placebo) | 1 | 21 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Group (Dexamethasone) | 0 | 20 |
| Total, all-cause mortality | Controlled Group (Placebo) | 0 | 21 |
| Total, other adverse events | Intervention Group (Dexamethasone) | 3 | 20 |
| Total, other adverse events | Controlled Group (Placebo) | 5 | 21 |
| Total, serious adverse events | Intervention Group (Dexamethasone) | 0 | 20 |
| Total, serious adverse events | Controlled Group (Placebo) | 0 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27330023 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Group (Dexamethasone) vs Controlled Group (Placebo): Number of Participants Who Completed the Dyspnea Numeric Rating Scale | Trial comparisons |
| Intervention Group (Dexamethasone) vs Controlled Group (Placebo): deaths from any cause | Trial comparisons |
| Intervention Group (Dexamethasone) vs Controlled Group (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.
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/NCT01670097
GET https://conductscience.org/api/trials/v1/NCT01670097/events?page=2