Trial Outcomes & Findings for Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer (NCT NCT02491632)
NCT ID: NCT02491632
Last Updated: 2025-10-28
Results Overview
FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level. We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
90 participants
Baseline, day 8, day 29
2025-10-28
Participant Flow
Patients were recruited from MD Anderson Cancer Center outpatients clinic for supportive are who has a diagnosis of advanced cancer with average intensity of fatigue of \>=4/10 on the ESAS scale in the previous 24 hours and presence of fatigue for at least 2 weeks.
A total of 90 patients were enrolled for this study. Of them 7 withdrew their consent, Doctor did not allow Dexamethasone for 3 cases, 2 had disease progression, and for 2 cases, their oncologist did not approve it. Thus a total of 76 participants were randomized.
Participant milestones
| Measure |
Physical Exercise + Low Dose Dexamethasone
Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days
|
Physical Exercise + High Dose Dexamethasone
Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Physical Exercise + Low Dose Dexamethasone
n=31 Participants
Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days
|
Physical Exercise + High Dose Dexamethasone
n=29 Participants
Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
58 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 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
|
1 Participants
n=5 Participants
|
0 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 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
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Cancer Diagnosis
Breast
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Cancer Diagnosis
Lung
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cancer Diagnosis
Gastrointestinal
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Cancer Diagnosis
Genitourinary
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Cancer Diagnosis
Other
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Assessment
Edmonton Symptom Assessment System (ESAS) Fatigue Score
|
6 units on a scale
n=5 Participants
|
6 units on a scale
n=7 Participants
|
6 units on a scale
n=5 Participants
|
|
Assessment
Hospital Anxiety and Depression Scale (HADS) Anxiety
|
4 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
5 units on a scale
n=5 Participants
|
|
Assessment
Hospital Anxiety and Depression Scale (HADS) Depression
|
6 units on a scale
n=5 Participants
|
7 units on a scale
n=7 Participants
|
6 units on a scale
n=5 Participants
|
|
Assessment
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale
|
23 units on a scale
n=5 Participants
|
20 units on a scale
n=7 Participants
|
21 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, day 8, day 29Population: Participants who completed the intervention.
FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level. We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.
Outcome measures
| Measure |
Physical Exercise + Low Dose Dexamethasone
n=31 Participants
Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days
|
Physical Exercise + High Dose Dexamethasone
n=29 Participants
Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days
|
|---|---|---|
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29
Change between Baseline and Day 8
|
9 score on a scale
Interval 3.0 to 19.0
|
8 score on a scale
Interval 3.0 to 18.0
|
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29
Change between Baseline and Day 29
|
10 score on a scale
Interval 4.0 to 16.0
|
12 score on a scale
Interval 7.0 to 20.0
|
SECONDARY outcome
Timeframe: Baseline, day 8, day 29Population: Participants who completed the intervention.
The PROMIS-F (Patient Reported Outcome Measurement Information System-Fatigue) short form was used to measure the experience of fatigue in patients' daily activities over the past week. It consists of 7 items with response options on a 5-point Likert scale, ranging from 1 (never) to 5 (always). We measured the change in PROMIS-F score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test. The total score is used in the analysis and is obtained by summing keyed scores of all items. Scores can range from 7 to 35, with higher scores indicating greater fatigue.
Outcome measures
| Measure |
Physical Exercise + Low Dose Dexamethasone
n=31 Participants
Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days
|
Physical Exercise + High Dose Dexamethasone
n=29 Participants
Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days
|
|---|---|---|
|
Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total
Change between Baseline and Day 8
|
-3 units on a scale
Interval -8.0 to 0.0
|
-4 units on a scale
Interval -8.0 to 0.0
|
|
Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total
Change between Baseline and Day 29
|
-9 units on a scale
Interval -20.0 to 0.0
|
-7 units on a scale
Interval -9.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline, day 8, day 29Population: Participants who completed the intervention.
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 wellbeing. We measured the change in ESAS fatigue score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test. Total ESAS fatigue score ranges from 0-10, with a higher score indicating higher fatigue.
Outcome measures
| Measure |
Physical Exercise + Low Dose Dexamethasone
n=31 Participants
Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days
|
Physical Exercise + High Dose Dexamethasone
n=29 Participants
Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days
|
|---|---|---|
|
Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue
Change between Baseline and Day 8
|
-1.5 score on a scale
Interval -3.0 to 0.0
|
-2 score on a scale
Interval -3.0 to 0.0
|
|
Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue
Change between Baseline and Day 29
|
-1.5 score on a scale
Interval -5.0 to 0.0
|
-3 score on a scale
Interval -4.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline, day 8, day 29Population: Participants who completed the intervention.
The MFSI-SF is a 30-item scale used to assess the multidimensional nature of fatigue. Responses are selected using a 5-point scale, ranging from 0 (not at all) to 4 (extremely fatigue). It consists of 5 subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue and vigor. The MFSI-SF total score is the sum of the general fatigue, physical fatigue, emotional fatigue and mental fatigue subscale score and subtracting vigor subscale score. Thus MFSI-SF total score ranges from 24-96, with a higher score indicating a higher fatigue level. We measured the change in MFSI-SF total score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.
Outcome measures
| Measure |
Physical Exercise + Low Dose Dexamethasone
n=31 Participants
Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days
|
Physical Exercise + High Dose Dexamethasone
n=29 Participants
Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days
|
|---|---|---|
|
Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score
Change between Baseline and Day 29
|
-6 score on a scale
Interval -10.0 to -1.0
|
-4.5 score on a scale
Interval -15.5 to 6.5
|
|
Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score
Change between Baseline and Day 8
|
-9 score on a scale
Interval -16.0 to -3.0
|
-5 score on a scale
Interval -16.0 to 3.0
|
Adverse Events
Physical Exercise + Low Dose Dexamethasone
Physical Exercise + High Dose Dexamethasone
Serious adverse events
| Measure |
Physical Exercise + Low Dose Dexamethasone
n=31 participants at risk
Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days
|
Physical Exercise + High Dose Dexamethasone
n=29 participants at risk
Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days
|
|---|---|---|
|
Eye disorders
Eye Infection
|
0.00%
0/31 • Baseline up to Day 29
|
3.4%
1/29 • Baseline up to Day 29
|
|
General disorders
Fatigue
|
3.2%
1/31 • Baseline up to Day 29
|
0.00%
0/29 • Baseline up to Day 29
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/31 • Baseline up to Day 29
|
3.4%
1/29 • Baseline up to Day 29
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/31 • Baseline up to Day 29
|
3.4%
1/29 • Baseline up to Day 29
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • Baseline up to Day 29
|
0.00%
0/29 • Baseline up to Day 29
|
|
Infections and infestations
Kidney Infection
|
3.2%
1/31 • Baseline up to Day 29
|
3.4%
1/29 • Baseline up to Day 29
|
|
Cardiac disorders
Sinus Tachycardia
|
3.2%
1/31 • Baseline up to Day 29
|
0.00%
0/29 • Baseline up to Day 29
|
|
Vascular disorders
Thromboembolic Event
|
3.2%
1/31 • Baseline up to Day 29
|
0.00%
0/29 • Baseline up to Day 29
|
Other adverse events
Adverse event data not reported
Additional Information
Sriram Yennu,MD- Professor, Palliative Care Med
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place