Acute Myeloid LeukemiaNCT05458258
Studying Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia and Leukemia, Myeloid, run by University of Chicago at 1 site in United States.
Trial summary
This study will explore how malnutrition (poor nutrition/diet) and sarcopenia (a condition that causes a loss of muscle and bone mass) affects study participants over the age of 60 with acute myeloid leukemia (AML) who will receive induction chemotherapy (chemotherapy given as the first treatment to help cancer go… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Leukemia, Myeloid
- What is being tested?
- Bioelectrical Impedence Analysis Device, 6 Minute Walk Test and Computed Tomography Scans to Measure Skeletal Muscular Index
- Type of treatment
- Medical device
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 18 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Study population: Adults with acute myeloid leukemia over the age of 60 who plan to receive induction therapy and/or cancer drugs for treatment.
Who may be able to join
- Older Adult patients (greater than or equal to 60 years of age)
- New diagnosis of acute myeloid leukemia (AML)
- Receiving induction therapy (intensive or low intensity therapy)
- Willing and able to provide written informed consent
Who cannot join
- Presence of a pacemaker or defibrillator.
- Participants who are pregnant at the time of enrollment.
- Anyone unable/unwilling to follow protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
About this study
Official title: Investigating The Prognostic Significance Of Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia
This study will explore how malnutrition (poor nutrition/diet) and sarcopenia (a condition that causes a loss of muscle and bone mass) affects study participants over the age of 60 with acute myeloid leukemia (AML) who will receive induction chemotherapy (chemotherapy given as the first treatment to help cancer go into remission) and/or cancer drugs as part of standard care for AML. By studying how these nutritional and skeletal factors, doctors leading this study hope to learn how malnutrition and sarcopenia may be able to predict certain outcomes --such as how long study participants with poor nutrition and muscle loss can live after chemotherapy- for older (age 60+) individuals with AML.
- Conditions
- Acute Myeloid Leukemia, Leukemia, Myeloid
- Being tested
- Bioelectrical Impedence Analysis Device, 6 Minute Walk Test, Computed Tomography Scans to Measure Skeletal Muscular Index, Blood Test/Blood Draw, Hand Grip Strength Test
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical Impedence Analysis DeviceDevice
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 TestOther
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 IndexDiagnostic test
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 DrawDiagnostic test
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 TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bioelectrical Impedence Analysis Device; Other: 6 Minute Walk Test; Diagnostic Test: Computed Tomography Scans to Measure Skeletal Muscular Index; Diagnostic Test: Blood Test/Blood Draw; Other: Hand Grip Strength Test | |
| 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. Receives: Device: Bioelectrical Impedence Analysis Device; Other: 6 Minute Walk Test; Diagnostic Test: Computed Tomography Scans to Measure Skeletal Muscular Index; Diagnostic Test: Blood Test/Blood Draw; Other: Hand Grip Strength Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Mortality Rates Based on Incidence of Sarcopenia in All Study Participants
This study's primary endpoint aims to measure the association of sarcopenia in study participants with their treatment-related mortality rate (how long the participant can stay alive 60 days after study treatment/registration). The incidence of sarcopenia in study participants will be measured using computed tomography-defined skeletal muscular index , hand grip strength test, and a 6-minute walk test. Treatment related mortality will be defined as the percent of patients no longer alive at 60 days after study registration.
Measured: 60 days
Secondary outcomes (3)
The prognostic impact of malnutrition and sarcopenia on treatment-related mortality rates and overall survival in study participants with AML
After pre-induction assessment (including assessments for sarcopenia and malnutrition), subjects will be prospectively followed for treatment-related mortality and overall survival assessments. Overall survival will be measured from date participants start on study to either death or last follow-up in accordance with 2017 European Leukemia Net recommendations. Treatment-related mortality rates will be defined as the percent of patients no longer alive at 60 days after registration.
Measured: 60 days
Incidence of Malnutrition Among Participants in Group 1 Compared to Incidence of Malnutrition in Healthy Control Group
The incidence of malnutrition in older adults (≥60 years) with newly diagnosed AML undergoing intensive induction chemotherapy compared to the incidence of malnutrition in participants in the healthy control group. Incidence of malnutrition in both groups will be as assessed by participant questionnaires (known as subjective global assessments), blood tests , and Standardized bioelectrical impedance (BI) phase angle ( a measurement of the participant's body mass using a medical device).
Measured: 60 days
Incidence of Sarcopenia Among Participants in Group 1 Compared to Incidence of Sarcopenia in Healthy Control Group
Incidence of sarcopenia in both study groups will be assessed by will be assessed by using computed tomography-defined skeletal mass index at L1, hand grip strength, and a 6-minute walk test.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Mar 2023
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Stock, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458258
- Sponsor's protocol ID
- IRB22-0397
- Status last verified
- Apr 2025
- First submitted
- 11 Jul 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating The Prognostic Significance Of Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05458258
- Acronym / sponsor ID
- IRB22-0397
- Conditions
- Acute Myeloid Leukemia, Leukemia, Myeloid
- Keywords
- AML
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore how malnutrition (poor nutrition/diet) and sarcopenia (a condition that causes a loss of muscle and bone mass) affects study participants over the age of 60 with acute myeloid leukemia (AML) who will receive induction chemotherapy (chemotherapy given as the first treatment to help cancer go into remission) and/or cancer drugs as part of standard care for AML. By studying how these nutritional and skeletal factors, doctors leading this study hope to learn how malnutrition and sarcopenia may be able to predict certain outcomes --such as how long study participants with poor nutrition and muscle loss can live after chemotherapy- for older (age 60+) individuals with AML.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults (age 60+) with Newly Diagnosed AML | – | Device: Bioelectrical Impedence Analysis Device, Other: 6 Minute Walk Test, Diagnostic Test: Computed Tomography Scans to Measure Skeletal Muscular Index, Diagnostic Test: Blood Test/Blood Draw, Other: Hand Grip Strength TestThis 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. |
| Healthy Control Group: Adults with AML (age 60+) in Good Health | – | Device: Bioelectrical Impedence Analysis Device, Other: 6 Minute Walk Test, Diagnostic Test: Computed Tomography Scans to Measure Skeletal Muscular Index, Diagnostic Test: Blood Test/Blood Draw, Other: Hand Grip Strength TestThis 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with acute myeloid leukemia over the age of 60 who plan to receive induction therapy and/or cancer drugs for treatment.
Key inclusion criteria (4 listed)
- Older Adult patients (greater than or equal to 60 years of age)
- New diagnosis of acute myeloid leukemia (AML)
- Receiving induction therapy (intensive or low intensity therapy)
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Presence of a pacemaker or defibrillator.
- Participants who are pregnant at the time of enrollment.
- Anyone unable/unwilling to follow protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectrical Impedence Analysis DeviceA 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. | Device | Adults (age 60+) with Newly Diagnosed AML, Healthy Control Group: Adults with AML (age 60+) in Good Health |
| 6 Minute Walk TestDefined 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. | Other | Adults (age 60+) with Newly Diagnosed AML, Healthy Control Group: Adults with AML (age 60+) in Good Health |
| Computed Tomography Scans to Measure Skeletal Muscular IndexComputed 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). | Diagnostic test | Adults (age 60+) with Newly Diagnosed AML, Healthy Control Group: Adults with AML (age 60+) in Good Health |
| Blood Test/Blood DrawBlood will be drawn through a need inserted into the participant's arm. This blood will be used to measure the participant's nutrition levels. | Diagnostic test | Adults (age 60+) with Newly Diagnosed AML, Healthy Control Group: Adults with AML (age 60+) in Good Health |
| Hand Grip Strength TestGrip 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. | Other | Adults (age 60+) with Newly Diagnosed AML, Healthy Control Group: Adults with AML (age 60+) in Good Health |
Primary outcome
Treatment-Related Mortality Rates Based on Incidence of Sarcopenia in All Study Participants
Time frame: 60 days
This study's primary endpoint aims to measure the association of sarcopenia in study participants with their treatment-related mortality rate (how long the participant can stay alive 60 days after study treatment/registration). The incidence of sarcopenia in study participants will be measured using computed tomography-defined skeletal muscular index , hand grip strength test, and a 6-minute walk test. Treatment related mortality will be defined as the percent of patients no longer alive at 60 days after study registration.
3 secondary outcomes
The prognostic impact of malnutrition and sarcopenia on treatment-related mortality rates and overall survival in study participants with AML
Time frame: 60 days
Incidence of Malnutrition Among Participants in Group 1 Compared to Incidence of Malnutrition in Healthy Control Group
Time frame: 60 days
Incidence of Sarcopenia Among Participants in Group 1 Compared to Incidence of Sarcopenia in Healthy Control Group
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Stock, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Leukemia, Myeloid, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Related Mortality Rates Based on Incidence of Sarcopenia in All Study Participants (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.