Trial Outcomes & Findings for Dexamethasone Dyspnea Study (NCT NCT01670097)
NCT ID: NCT01670097
Last Updated: 2021-02-17
Results Overview
Number of participants who completed the dyspnea numeric rating scale on Day 7
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Baseline to Day 7
Results posted on
2021-02-17
Participant Flow
Adult cancer patient with lung involvement were recruited between 1/2013 and 5/2015 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who satisfied the inclusion and exclusion criteria.
A total of 52 participants enrolled for this study. Among them, 41 patients were randomized. 6 participants declined to continue and 5 participants became ineligible (3 started steroids, 2 had other reasons) before randomization, thus a total of 11 participants were dropped out before randomization.
Participant milestones
| Measure |
Intervention Group (Dexamethasone)
Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Controlled Group (Placebo)
Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
Completed Week 1 Intervention
|
18
|
17
|
|
Overall Study
Completed Week 2 Intervention
|
13
|
15
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Intervention Group (Dexamethasone)
Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Controlled Group (Placebo)
Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
|---|---|---|
|
Overall Study
Started Phase 1 cancer treatment
|
1
|
0
|
|
Overall Study
Study burden
|
1
|
0
|
|
Overall Study
COPD exacerbation
|
0
|
1
|
|
Overall Study
Neutropenia
|
0
|
1
|
|
Overall Study
Clinical deterioration
|
0
|
1
|
|
Overall Study
Disease progression
|
0
|
1
|
Baseline Characteristics
Dexamethasone Dyspnea Study
Baseline characteristics by cohort
| Measure |
Intervention Group (Dexamethasone)
n=20 Participants
Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Controlled Group (Placebo)
n=21 Participants
Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Education
High School or less
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Education
College and above
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cancer Type
Mesothelioma
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cancer Type
Non-small cell lung cancer
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Cancer Type
Small cell lung cancer
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer Type
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cancer Stage
Localized
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Cancer Stage
Locally advanced
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cancer Stage
Metastatic/recurrent
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Comorbidities
COPD
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Comorbidities
Asthma
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 7Population: Baseline Analysis included all randomized participants, 20 participants in intervention arm and 21 participants in control arm
Number of participants who completed the dyspnea numeric rating scale on Day 7
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=20 Participants
Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Controlled Group (Placebo)
n=21 Participants
Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
|---|---|---|
|
Number of Participants Who Completed the Dyspnea Numeric Rating Scale
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 4, Day 7, Day 14Population: 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.
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.
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=19 Participants
Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Controlled Group (Placebo)
n=19 Participants
Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
|---|---|---|
|
Edmonton Symptom Assessment System Dyspnea Score
Day 4
|
-1.9 score on a scale
Interval -3.3 to -0.5
|
-0.7 score on a scale
Interval -2.1 to 0.6
|
|
Edmonton Symptom Assessment System Dyspnea Score
Day 7
|
-1.8 score on a scale
Interval -3.2 to -0.3
|
-1.3 score on a scale
Interval -2.4 to -0.2
|
|
Edmonton Symptom Assessment System Dyspnea Score
Day 14
|
-2.1 score on a scale
Interval -3.5 to -0.6
|
-1.7 score on a scale
Interval -2.7 to -0.7
|
SECONDARY outcome
Timeframe: Baseline to day 4, Day 7 and Day 14Population: 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.
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.
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=19 Participants
Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Controlled Group (Placebo)
n=19 Participants
Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
|---|---|---|
|
Dyspnea Numeric Rating Score (Now)
Day 4
|
0 score on a scale
Interval -1.0 to 1.0
|
-0.1 score on a scale
Interval -1.1 to 1.0
|
|
Dyspnea Numeric Rating Score (Now)
Day 7
|
-1.1 score on a scale
Interval -2.4 to 0.2
|
-0.2 score on a scale
Interval -1.6 to 1.2
|
|
Dyspnea Numeric Rating Score (Now)
Day 14
|
-1.6 score on a scale
Interval -3.0 to -0.2
|
-1.5 score on a scale
Interval -2.5 to -0.5
|
SECONDARY outcome
Timeframe: Baseline to day 4, Day 7 and Day 14.Population: 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.
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.
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=19 Participants
Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Controlled Group (Placebo)
n=19 Participants
Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
|---|---|---|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea
Day 7
|
-10.4 score on a scale
Interval -21.1 to 0.3
|
-5.1 score on a scale
Interval -19.0 to 8.8
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea
Day 14
|
-7.7 score on a scale
Interval -22.3 to 6.9
|
-6.7 score on a scale
Interval -19.2 to 5.8
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea
Day 4
|
-15.6 score on a scale
Interval -29.3 to -1.8
|
0 score on a scale
Interval -14.0 to 14.0
|
Adverse Events
Intervention Group (Dexamethasone)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Controlled Group (Placebo)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group (Dexamethasone)
n=20 participants at risk
Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
Controlled Group (Placebo)
n=21 participants at risk
Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.
|
|---|---|---|
|
Nervous system disorders
Anxiety/Irritability
|
10.0%
2/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
0.00%
0/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
0.00%
0/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
9.5%
2/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Gastrointestinal disorders
Halitosis
|
5.0%
1/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
0.00%
0/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
General disorders
Edema
|
15.0%
3/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Nervous system disorders
Hiccup
|
5.0%
1/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
0.00%
0/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Nervous system disorders
Hot flash
|
5.0%
1/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
0.00%
0/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Gastrointestinal disorders
Hyperglycemia
|
5.0%
1/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Nervous system disorders
Hyperhidrosis
|
5.0%
1/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
0.00%
0/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
General disorders
Insomnia
|
10.0%
2/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
23.8%
5/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Nervous system disorders
Blurred vision
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
9.5%
2/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
General disorders
Fatigue
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
14.3%
3/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Nervous system disorders
Flasing
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Gastrointestinal disorders
Mouth sores
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Gastrointestinal disorders
Taste changes
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
General disorders
Fever
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
19.0%
4/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Nervous system disorders
Pain
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
9.5%
2/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
9.5%
2/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
4.8%
1/21 • Baseline to Day 4, Day 7, and Day 14.
As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.
|
Additional Information
David Hui, MD/ Associate Professor, Palliative Care Medicine
UT MD Anderson Cancer Center
Phone: (713) 792-6258
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place