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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01129 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0591 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well dexamethasone works in controlling dyspnea in patients with cancer. Dexamethasone may help control dyspnea (shortness of breath) and improve lung function and quality of life in cancer patients.
PRIMARY OBJECTIVES:
I. Compare the intensity of dyspnea (numeric rating scale [NRS]) in the dexamethasone arm with that in the placebo arm at week 1.
SECONDARY OBJECTIVES:
I. Compare the effects of dexamethasone with those of placebo in terms of personalized dyspnea response (based on a personalized dyspnea goal), unpleasantness of dyspnea, other symptoms, health-related quality of life, respiratory physiologic function, and adverse effects at week 1 and week 2, as well as the intensity of dyspnea at week 2.
II. Identify predictive markers of dyspnea response to dexamethasone.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive dexamethasone orally (PO) twice daily (BID) on days 1-28 in the absence of disease progression or unacceptable toxicity.
GROUP II: 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.
After completion of study treatment, patients are followed up at days 28 and 42.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (dexamethasone) | Experimental | Patients receive dexamethasone PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. |
|
| Group II (placebo, dexamethasone) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity | 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. | Baseline and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hui | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson Hospital | Houston | Texas | 77026 | United States | ||
| Harris Health System Settegast Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42018190 | Derived | Hui D, Jennings K, Ontai A, Hanneman SK, Bruera E. Predictive biomarkers of placebo response in patients with cancer: an exploratory analysis of the ABCD randomized clinical trial. Support Care Cancer. 2026 Apr 22;34(5):452. doi: 10.1007/s00520-026-10689-9. | |
| 36087590 | Derived | 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. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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A total of 135 participants were enrolled but 128 were randomized. 7 participants were not randomized for various reasons.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity | 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. | The Dyspnea Average Intensity Numeric score was missing for 4 participants in the Dexamethasone Arm and 1 participant in the Placebo Arm. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Day 7 |
|
Day 0 to Day 14
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Hui- Professor, Palliative Care Medicine | UT MD Anderson Cancer Center | (713) 792-6258 | dhui@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2022 | Sep 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| C059464 | auricularum |
| C018038 | dexamethasone acetate |
| C004180 | dexamethasone 21-phosphate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Other | Given PO |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Baseline and Day 14 |
| Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness | 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. | Baseline and Day 7 |
| Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between 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. | Baseline and Day 7 |
| Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between 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. | Baseline and Day 7 |
| Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness | 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. | Baseline and Day 14 |
| Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between 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. | Baseline and Day 14 |
| Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between 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. | Baseline and Day 14 |
| Houston |
| Texas |
| 77028 |
| United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Lost to Follow-up |
|
| Became ineligible |
|
| Hospitalization |
|
| Concerned about Treatment |
|
| Started new treatment |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cancer Stage | Stage IV has the worst outcome. | Count of Participants | Participants |
|
| Cancer Type | Count of Participants | Participants |
|
| Comorbidity | Count of Participants | Participants |
|
| OG001 |
| Placebo |
Participants were given 2capsules (4mg each) twice daily (Day1-Day7), then 1 capsule twice daily for the next 7 days (Day 8-Day14). |
|
|
|
| Secondary | Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity | 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. | Participants who were on the study at day 14 and received assessment. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Day 14 |
|
|
|
|
| Secondary | Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness | 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. | The Dyspnea Average Unpleasantness Numeric score was missing for 4 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Day 7 |
|
|
|
|
| Secondary | Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between 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. | The ESAS Dyspnea Numeric score was missing for 3 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Day 7 |
|
|
|
|
| Secondary | Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between 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. | The EORTC QLQ-C30 Dyspnea score was missing for 4 participants in the Dexamethasone Arm and 2 participant in the Placebo Arm. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Day 7 |
|
|
|
|
| Secondary | Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness | 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Day 14 |
|
|
|
|
| Secondary | Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Day 14 |
|
|
|
|
| Secondary | Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Day 14 |
|
|
|
|
| 2 |
| 85 |
| 24 |
| 85 |
| 32 |
| 85 |
| EG001 | 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). | 0 | 43 | 3 | 43 | 7 | 43 |
| Cardiac Arrest | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
|
| Catheter related infection | Renal and urinary disorders | CTCAE (4.03) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.03) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.03) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Lung Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Pyschosis | Psychiatric disorders | CTCAE (4.03) | Systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Thromboembolic Event | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
|
| Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Pain | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Neuropsychiatric symptoms | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Infection | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |