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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01320 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2014-0436 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer.
PRIMARY OBJECTIVES:
1. To determine the feasibility, adherence, and satisfaction with physical activity (PA) plus dexamethasone (PA+ DEX).
SECONDARY OBJECTIVES:
I. To explore the preliminary efficacy of PA+ Hi Dex group (PA for 4 weeks plus high dose dexamethasone for 1 week) and PA + Lo Dex groups (PA for 4 weeks plus low dose dexamethasone for 1 week) on cancer-related fatigue (CRF) as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at the end of one week.
II. To explore the effects of PA+ Hi Dex on the various dimensions of CRF (Patient-Reported Outcomes Measurement Information System-Fatigue [PROMIS-F]), i.e., affective/emotional (Hospital Anxiety Depression Scale [HADS]); physical/behavioral (the Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Pittsburg Sleep Quality Index), physical activity and function (30 second sit-to stand test, six minute walk test) before and after treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive high-dose dexamethasone orally (PO) twice daily (BID) for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
ARM II: Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.
After completion of study, patients are followed up at day 29 and again after 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (high-dose dexamethasone, physical activity) | Experimental | Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary. |
|
| Arm II (low dose dexamethasone, physical activity) | Experimental | Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29 | 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. | Baseline, day 8, day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sriram Yennu | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34965510 | Derived | Yennurajalingam S, Valero V, Lu Z, Liu DD, Busaidy NL, Reuben JM, Diaz Fleming C, Williams JL, Hess KR, Basen-Engquist K, Bruera E. Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial. J Natl Compr Canc Netw. 2021 Dec 29;20(3):235-243. doi: 10.6004/jnccn.2021.7066. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Exercise + Low Dose Dexamethasone | Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days |
| FG001 | Physical Exercise + High Dose Dexamethasone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 17, 2016 |
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| Exercise Intervention | Behavioral | Complete a graded resistance exercise program and a walking regimen |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Baseline, day 8, day 29 |
| Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue | 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. | Baseline, day 8, day 29 |
| Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score | 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. | Baseline, day 8, day 29 |
Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days
| COMPLETED |
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| NOT COMPLETED |
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Participants who completed the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Exercise + Low Dose Dexamethasone | Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days |
| BG001 | Physical Exercise + High Dose Dexamethasone | Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Cancer Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Assessment | Edmonton Symptom Assessment System (ESAS) Fatigue score ranges from 0-10, higher score indicates higher fatigue. Hospital Anxiety and Depression Scale (HADS) Anxiety scores ranges from 0-21, higher score indicates higher anxiety. Hospital Anxiety and Depression Scale (HADS) Depression score ranges from 0-21, higher score indicates higher depression. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale score ranges from 0-52, lower score indicates higher fatigue. | Median | Inter-Quartile Range | units on a scale |
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| 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 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29 | 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. | Participants who completed the intervention. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, day 8, day 29 |
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| Secondary | Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total | 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. | Participants who completed the intervention. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, day 8, day 29 |
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| Secondary | Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue | 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. | Participants who completed the intervention. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, day 8, day 29 |
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| Secondary | Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score | 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. | Participants who completed the intervention. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, day 8, day 29 |
|
Baseline up to Day 29
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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 | Physical Exercise + Low Dose Dexamethasone | Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days | 0 | 31 | 5 | 31 | 0 | 31 |
| EG001 | Physical Exercise + High Dose Dexamethasone | Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days | 1 | 29 | 4 | 29 | 0 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Infection | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Kidney Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Thromboembolic Event | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sriram Yennu,MD- Professor, Palliative Care Med | UT MD Anderson Cancer Center | (713) 792-3938 | syennu@mdanderson.org |
| Jul 18, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D020969 | Disease Attributes |
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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 |
| 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 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Lung |
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| Gastrointestinal |
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| Genitourinary |
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| Other |
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| Hospital Anxiety and Depression Scale (HADS) Anxiety |
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| Hospital Anxiety and Depression Scale (HADS) Depression |
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| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale |
|
| <.001 |
| Other |
| Change between Baseline and Day 8 | Wilcoxon (Mann-Whitney) | <.001 | Other |
| Change between Baseline and Day 29 | Wilcoxon (Mann-Whitney) | <.001 | Other |
| Participants |
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| Units | Counts |
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| Participants |
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