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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05460 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-0141 | Other Identifier | M D Anderson Cancer Center |
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Terminated early due to slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial investigates the changes in physical and functional tests over time in patients with suspected acute graft versus host disease (from a hematologic stem cell transplant) who started treatment with corticosteroids. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Steroids are used to treat suspected graft-versus-host disease. Steroid myopathy (muscle weakness and fatigue) is a significant side effect of high dose steroid therapy, and can impair activities of daily of life. The goal of this trial is to learn how patients' physical activities and functions change over time while on GVHD-steroid treatment.
PRIMARY OBJECTIVE:
I. To perform a pilot study to estimate the change in six physical and functional tests over time in patients with suspected acute graft-versus-host disease (GVHD) who have been initiated on treatment with corticosteroids.
SECONDARY OBJECTIVES:
I. To describe and potentially define steroid myopathy by following the patterns of the muscle loss and functional impairment in this population of patients.
II. To follow steroid myopathy and describe its incidence, its severity, and the impact on non-relapse mortality in a homogeneous population of patients with suspected acute graft-versus-host disease (GVHD) who have been initiated on treatment with corticosteroids at a quaternary institution in the inpatient and outpatient setting.
III. To estimate the adherence to an intermittently supervised exercise program in hematopoietic stem cell transplantation (HSCT) patients who are at risk of developing steroid myopathy.
OUTLINE:
Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (exercise intervention) | Experimental | Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Participate in an 8-week home-based strengthening and walking program |
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| Measure | Description | Time Frame |
|---|---|---|
| 6 Minutes Walk Test | 6 minute walk test (measured in meters) was conducted on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0, and Day 56 minus Day 0. | Baseline, Day 14, Day 28 and Day 56 |
| 5 Times Sit to Stand (5xSTS) | 5xSTS was measured in seconds on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0. | Baseline, Day 14, Day 28 and Day 56 |
| Brooke Scale for Myopathy | Brooke Scale for myopathy (a score from 0 to 6, with 6 being the best score with full range of motion of the arms) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0 | Baseline, Day 14, Day 28 and Day 56 |
| Modified Adult Myopathy Assessment Tool | The modified Adult Myopathy Assessment Tool assigns a numerical score to a series of physical tasks (arm raise [0 to 3], sustained arm raise [0 to 4], single sit-to-stand [0 to 3], sustained hip flexion [0 to 4], and sustained knee extension [0 to 4]). The total score of all test components (0 to 18) is reported, with 18 as the highest score for muscle function and endurance. | Baseline, Day 14, Day 28 and Day 56 |
| Knee Extensors Strength | Knee Extensors Strength (in pounds) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median change for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0. | Baseline, Day 14, Day 28 and Day 56 |
| Hip Flexors Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| An T Ngo-Huang | 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 |
|---|---|---|---|
| 33278131 | Derived | Ngo-Huang A, Yadav R, Bansal S, Williams J, Wu J, Fu JB, Alousi AM, Bruera E. An Exploratory Study on Physical Function in Stem Cell Transplant Patients Undergoing Corticosteroid Treatment for Acute Graft-Versus-Host-Disease. Am J Phys Med Rehabil. 2021 Apr 1;100(4):402-406. doi: 10.1097/PHM.0000000000001660. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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Patients who were treated with high dose corticosteroid for Acute Graft Versus Host Disease at MD Anderson Cancer Center between October 2015 and April 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | In this single-arm trial, patients who were started on high dose corticosteroids (methylprednisolone or equivalent, 2mg/kg/day) for suspected Acute Graft Versus Host Disease were enrolled on the trial. In order monitor for muscle weakness, serial physical function measures were obtained (baseline, Day 14 after enrollment, Day 28, and Day 56). All enrolled patients were also instructed on a home-based exercise program. |
| 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 | Feb 21, 2017 |
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| Physical Performance Testing | Other | Complete a physical function test |
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| Questionnaire Administration | Other | Ancillary studies |
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Hip Flexors Strength (in pounds) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0. |
| Baseline, Day 14, Day 28 and Day 56 |
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| NOT COMPLETED |
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Data for the 23 participants were analyzed. 1 participant was inevaluable.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | In this single-arm trial, patients who were started on high dose corticosteroids (methylprednisolone or equivalent, 2mg/kg/day) for suspected Acute Graft Versus Host Disease were enrolled on the trial. In order monitor for muscle weakness, serial physical function measures were obtained (baseline, Day 14 after enrollment, Day 28, and Day 56). All enrolled patients were also instructed on a home-based exercise program. |
| 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 | Full 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 |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Median | Full Range | kg/m^2 |
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| Primary Cancer | Count of Participants | Participants |
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| Cancer Status | Count of Participants | Participants |
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| Graft Source | Count of Participants | Participants |
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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 | 6 Minutes Walk Test | 6 minute walk test (measured in meters) was conducted on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0, and Day 56 minus Day 0. | Posted | Median | Full Range | meters | Baseline, Day 14, Day 28 and Day 56 |
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| Primary | 5 Times Sit to Stand (5xSTS) | 5xSTS was measured in seconds on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0. | Posted | Median | Full Range | seconds | Baseline, Day 14, Day 28 and Day 56 |
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| Primary | Brooke Scale for Myopathy | Brooke Scale for myopathy (a score from 0 to 6, with 6 being the best score with full range of motion of the arms) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0 | Posted | Median | Full Range | score on a scale | Baseline, Day 14, Day 28 and Day 56 |
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| Primary | Modified Adult Myopathy Assessment Tool | The modified Adult Myopathy Assessment Tool assigns a numerical score to a series of physical tasks (arm raise [0 to 3], sustained arm raise [0 to 4], single sit-to-stand [0 to 3], sustained hip flexion [0 to 4], and sustained knee extension [0 to 4]). The total score of all test components (0 to 18) is reported, with 18 as the highest score for muscle function and endurance. | Posted | Median | Full Range | score on a scale | Baseline, Day 14, Day 28 and Day 56 |
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| Primary | Knee Extensors Strength | Knee Extensors Strength (in pounds) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median change for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0. | Posted | Median | Full Range | pounds | Baseline, Day 14, Day 28 and Day 56 |
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| Primary | Hip Flexors Strength | Hip Flexors Strength (in pounds) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0. | Posted | Median | Full Range | pounds | Baseline, Day 14, Day 28 and Day 56 |
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56 Days
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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 | All Participants | In this single-arm trial, patients who were started on high dose corticosteroids (methylprednisolone or equivalent, 2mg/kg/day) for suspected Acute Graft Versus Host Disease were enrolled on the trial. In order monitor for muscle weakness, serial physical function measures were obtained (baseline, Day 14 after enrollment, Day 28, and Day 56). All enrolled patients were also instructed on a home-based exercise program. | 3 | 24 | 0 | 24 | 0 | 24 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| An T Ngo-Huang, Assistant Professor, Rehabilitation Medicine | UT MD Anderson Cancer Center | (713) 745-2327 | ango2@mdanderson.org |
| Oct 21, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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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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| B cell Lymphoma |
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| Chronic Myeloid Leukemia |
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| Chronic Lymphocytic Leukemia |
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| Acute Lymphocytic Leukemia |
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| Myelofibrosis |
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| Remission |
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| Title | Measurements |
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