Trial Outcomes & Findings for Dexamethasone for Symptom Burden in Advanced Cancer Patients (NCT NCT00489307)
NCT ID: NCT00489307
Last Updated: 2025-11-12
Results Overview
FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. It was measured as change in symptom score from Baseline to Day 15.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Baseline to Day 15
Results posted on
2025-11-12
Participant Flow
Patients with advanced cancer with \>= three Cancer related fatigue symptoms (ie, fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance) \>= 4 of 10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.
Participant milestones
| Measure |
Intervention Group (Dexamethasone)
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
65
|
|
Overall Study
COMPLETED
|
43
|
41
|
|
Overall Study
NOT COMPLETED
|
24
|
24
|
Reasons for withdrawal
| Measure |
Intervention Group (Dexamethasone)
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Hospitalization unrelated to treatment
|
10
|
7
|
|
Overall Study
Surgery after assignment
|
1
|
0
|
|
Overall Study
Did not fill up the forms
|
2
|
1
|
|
Overall Study
Patient or family refusal
|
5
|
9
|
Baseline Characteristics
Dexamethasone for Symptom Burden in Advanced Cancer Patients
Baseline characteristics by cohort
| Measure |
Intervention Group (Dexamethasone)
n=67 Participants
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
n=65 Participants
Placebo by mouth (PO) twice daily for 14 days.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
n=10 Participants
|
60 years
n=10 Participants
|
60 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=10 Participants
|
28 Participants
n=10 Participants
|
70 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=10 Participants
|
37 Participants
n=10 Participants
|
62 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
23 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=10 Participants
|
49 Participants
n=10 Participants
|
102 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=10 Participants
|
65 participants
n=10 Participants
|
132 participants
n=20 Participants
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
FACIT-F Subscale Score
|
18.4 score on a scale
STANDARD_DEVIATION 10.47 • n=10 Participants
|
21.57 score on a scale
STANDARD_DEVIATION 9.11 • n=10 Participants
|
19.64 score on a scale
STANDARD_DEVIATION 9.98 • n=20 Participants
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
FAACT Subscale score
|
23.91 score on a scale
STANDARD_DEVIATION 8.28 • n=10 Participants
|
25.69 score on a scale
STANDARD_DEVIATION 8.93 • n=10 Participants
|
24.84 score on a scale
STANDARD_DEVIATION 8.58 • n=20 Participants
|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
FACIT_F- Total score
|
88.66 score on a scale
STANDARD_DEVIATION 19.9 • n=10 Participants
|
77.1 score on a scale
STANDARD_DEVIATION 23.83 • n=10 Participants
|
80.85 score on a scale
STANDARD_DEVIATION 22.2 • n=20 Participants
|
|
Edmonton Symptom Assessment System (ESAS)
ESAS Nausea
|
2.64 score on a scale
STANDARD_DEVIATION 2.73 • n=10 Participants
|
2.28 score on a scale
STANDARD_DEVIATION 2.76 • n=10 Participants
|
2.46 score on a scale
STANDARD_DEVIATION 2.74 • n=20 Participants
|
|
Hospital Anxiety and Depression Scale (HADS)
HADS Anxiety score
|
7.47 score on a scale
STANDARD_DEVIATION 4.18 • n=10 Participants
|
7.46 score on a scale
STANDARD_DEVIATION 3.9 • n=10 Participants
|
7.46 score on a scale
STANDARD_DEVIATION 4.03 • n=20 Participants
|
|
Hospital Anxiety and Depression Scale (HADS)
HADS Depression score
|
9.03 score on a scale
STANDARD_DEVIATION 5.72 • n=10 Participants
|
4.22 score on a scale
STANDARD_DEVIATION 7.94 • n=10 Participants
|
8.5 score on a scale
STANDARD_DEVIATION 3.8 • n=20 Participants
|
|
Edmonton Symptom Assessment System (ESAS)
ESAS Pain
|
5.72 score on a scale
STANDARD_DEVIATION 2.43 • n=10 Participants
|
5.14 score on a scale
STANDARD_DEVIATION 2.8 • n=10 Participants
|
5.43 score on a scale
STANDARD_DEVIATION 2.63 • n=20 Participants
|
|
Edmonton Symptom Assessment System (ESAS)
ESAS Fatigue
|
7.38 score on a scale
STANDARD_DEVIATION 1.89 • n=10 Participants
|
5.14 score on a scale
STANDARD_DEVIATION 2.8 • n=10 Participants
|
7.05 score on a scale
STANDARD_DEVIATION 1.89 • n=20 Participants
|
|
Edmonton Symptom Assessment System (ESAS)
ESAS Depression
|
3.13 score on a scale
STANDARD_DEVIATION 3.16 • n=10 Participants
|
3.36 score on a scale
STANDARD_DEVIATION 3.11 • n=10 Participants
|
3.24 score on a scale
STANDARD_DEVIATION 3.13 • n=20 Participants
|
|
Edmonton Symptom Assessment System (ESAS)
ESAS Anxiety
|
3.64 score on a scale
STANDARD_DEVIATION 3.27 • n=10 Participants
|
3.69 score on a scale
STANDARD_DEVIATION 2.91 • n=10 Participants
|
3.66 score on a scale
STANDARD_DEVIATION 3.08 • n=20 Participants
|
|
Edmonton Symptom Assessment System (ESAS)
ESAS Drowsiness
|
4.14 score on a scale
STANDARD_DEVIATION 3.19 • n=10 Participants
|
4.2 score on a scale
STANDARD_DEVIATION 2.68 • n=10 Participants
|
4.17 score on a scale
STANDARD_DEVIATION 2.94 • n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 15Population: A total of 48 participants were excluded from the analysis for various reasons.
FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. It was measured as change in symptom score from Baseline to Day 15.
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=43 Participants
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
n=41 Participants
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores
|
9 score on a scale
Standard Deviation 10.3
|
3.1 score on a scale
Standard Deviation 9.59
|
SECONDARY outcome
Timeframe: Baseline to day 15ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15.
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=43 Participants
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
n=41 Participants
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Edmonton Symptom Assessment System (ESAS) Pain
|
-1.35 score on a scale
Standard Deviation 3.11
|
-0.17 score on a scale
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Baseline to Day 15ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=43 Participants
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
n=41 Participants
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Edmonton Symptom Assessment System (ESAS) Nausea
|
-1.08 score on a scale
Standard Deviation 2.95
|
-0.36 score on a scale
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: Baseline to day 15ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=43 Participants
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
n=41 Participants
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Edmonton Symptom Assessment System (ESAS) Appetite
|
-2.19 score on a scale
Standard Deviation 3.78
|
-0.63 score on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: Baseline to day 15HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15.
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=43 Participants
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
n=41 Participants
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Anxiety
|
-0.66 score on a scale
Standard Deviation 3.45
|
-1 score on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Baseline to day 15HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15.
Outcome measures
| Measure |
Intervention Group (Dexamethasone)
n=43 Participants
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
n=41 Participants
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Depression
|
-1.39 score on a scale
Standard Deviation 3.59
|
-0.31 score on a scale
Standard Deviation 3.9
|
Adverse Events
Intervention Group (Dexamethasone)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 1 deaths
(Control Group) Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group (Dexamethasone)
n=43 participants at risk
Dexamethasone 4 mg orally two times a day for 14 days.
|
(Control Group) Placebo
n=41 participants at risk
Placebo by mouth (PO) twice daily for 14 days.
|
|---|---|---|
|
Nervous system disorders
Pain
|
41.9%
18/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
26.8%
11/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Nervous system disorders
Insomnia
|
7.0%
3/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
14.6%
6/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
4.9%
2/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
0.00%
0/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
2.4%
1/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
14.6%
6/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
General disorders
Edema
|
2.3%
1/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
9.8%
4/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Nervous system disorders
Neuropathy
|
2.3%
1/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
0.00%
0/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
9.8%
4/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Nervous system disorders
Nausea/Vomiting
|
2.3%
1/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
7.3%
3/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Nervous system disorders
Blurred Vision
|
2.3%
1/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
0.00%
0/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Nervous system disorders
Depression
|
2.3%
1/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
0.00%
0/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
18.6%
8/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
14.6%
6/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
|
General disorders
Infection
|
9.3%
4/43 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
2.4%
1/41 • Baseline up to Day 15
Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
|
Additional Information
Dr. Sriram Yennu, Professor, Palliative Care Med
UT MD Anderson Cancer Center
Phone: (713) 792-3938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place