Studying Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia
NCT ID: NCT05458258
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
239 participants
OBSERVATIONAL
2023-03-01
2025-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Adults (age 60+) with Newly Diagnosed AML
This group will consist of participants age 60+ who will be assessed for malnutrition and sarcopenia. Participants in this group will undergo chemotherapy and/or receive cancer drugs (as part of standard care). Participants in this group will receive different assessments when they start induction therapy to measure their nutritional health and the severity of their sarcopenia.
Bioelectrical Impedence Analysis Device
A device that helps measure body composition, in particular body fat and muscle mass based on based on the rate at which an electrical current travels through the body.
6 Minute Walk Test
Defined as the distance the participant is able to walk in 6 minutes. Participants will be instructed to perform laps from the 0- to 30 minutes mark and back again for a total of 6 min in an outpatient or inpatient setting on a flat, pre-defined course. Participants will be instructed that goal of the test is to walk as far as possible.
Computed Tomography Scans to Measure Skeletal Muscular Index
Computed tomography scans (a type of x-ray) that will measure the skeletal muscular index (the ratio of the muscle in your arms and legs to your height).
Blood Test/Blood Draw
Blood will be drawn through a need inserted into the participant's arm. This blood will be used to measure the participant's nutrition levels.
Hand Grip Strength Test
Grip strength in both hands will be measured using an adjustable hydraulic grip strength dynamometer (a device that is gripped to measure hand strength). The best performance of three trials will be selected for each hand, with averages of the left and right hand used in analyses.
Healthy Control Group: Adults with AML (age 60+) in Good Health
This group will also consist of participants age 60+ who will be assessed for malnutrition and sarcopenia. Participants in this group will undergo induction therapy and/or receive cancer drugs to treat their AML (as part of standard care). Participants in this group will also receive different assessments when they start induction therapy to measure their nutritional health and the severity of their sarcopenia. Participants in this group will receive the same assessment as participants in the first study group -- the only difference is that participants in this group have been determined to be healthier than those in the first study group according to clinical assessments.
Bioelectrical Impedence Analysis Device
A device that helps measure body composition, in particular body fat and muscle mass based on based on the rate at which an electrical current travels through the body.
6 Minute Walk Test
Defined as the distance the participant is able to walk in 6 minutes. Participants will be instructed to perform laps from the 0- to 30 minutes mark and back again for a total of 6 min in an outpatient or inpatient setting on a flat, pre-defined course. Participants will be instructed that goal of the test is to walk as far as possible.
Computed Tomography Scans to Measure Skeletal Muscular Index
Computed tomography scans (a type of x-ray) that will measure the skeletal muscular index (the ratio of the muscle in your arms and legs to your height).
Blood Test/Blood Draw
Blood will be drawn through a need inserted into the participant's arm. This blood will be used to measure the participant's nutrition levels.
Hand Grip Strength Test
Grip strength in both hands will be measured using an adjustable hydraulic grip strength dynamometer (a device that is gripped to measure hand strength). The best performance of three trials will be selected for each hand, with averages of the left and right hand used in analyses.
Interventions
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Bioelectrical Impedence Analysis Device
A device that helps measure body composition, in particular body fat and muscle mass based on based on the rate at which an electrical current travels through the body.
6 Minute Walk Test
Defined as the distance the participant is able to walk in 6 minutes. Participants will be instructed to perform laps from the 0- to 30 minutes mark and back again for a total of 6 min in an outpatient or inpatient setting on a flat, pre-defined course. Participants will be instructed that goal of the test is to walk as far as possible.
Computed Tomography Scans to Measure Skeletal Muscular Index
Computed tomography scans (a type of x-ray) that will measure the skeletal muscular index (the ratio of the muscle in your arms and legs to your height).
Blood Test/Blood Draw
Blood will be drawn through a need inserted into the participant's arm. This blood will be used to measure the participant's nutrition levels.
Hand Grip Strength Test
Grip strength in both hands will be measured using an adjustable hydraulic grip strength dynamometer (a device that is gripped to measure hand strength). The best performance of three trials will be selected for each hand, with averages of the left and right hand used in analyses.
Eligibility Criteria
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Inclusion Criteria
* New diagnosis of acute myeloid leukemia (AML)
* Receiving induction therapy (intensive or low intensity therapy)
* Willing and able to provide written informed consent
Exclusion Criteria
* Participants who are pregnant at the time of enrollment.
* Anyone unable/unwilling to follow protocol requirements
60 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Wendy Stock, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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IRB22-0397
Identifier Type: -
Identifier Source: org_study_id
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