Studying Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia

Completed

• Conditions: Leukemia, Myeloid; Acute Myeloid Leukemia
• Interventions: 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

• Registration Number: NCT05458258
• Lead Sponsor: University of Chicago

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-14
• Study Start: 2023-03-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-18
• Study Completion: 2025-04-18
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

• 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

Exclusion Criteria

• Presence of a pacemaker or defibrillator.
• Participants who are pregnant at the time of enrollment.
• Anyone unable/unwilling to follow protocol requirements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults (age 60+) with Newly Diagnosed AML	6 Minute Walk Test	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.
Adults (age 60+) with Newly Diagnosed AML	Bioelectrical Impedence Analysis Device	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.
Adults (age 60+) with Newly Diagnosed AML	Computed Tomography Scans to Measure Skeletal Muscular Index	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.
Adults (age 60+) with Newly Diagnosed AML	Blood Test/Blood Draw	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.
Adults (age 60+) with Newly Diagnosed AML	Hand Grip Strength Test	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.
Healthy Control Group: Adults with AML (age 60+) in Good Health	6 Minute Walk Test	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.
Healthy Control Group: Adults with AML (age 60+) in Good Health	Bioelectrical Impedence Analysis Device	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.
Healthy Control Group: Adults with AML (age 60+) in Good Health	Blood Test/Blood Draw	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.
Healthy Control Group: Adults with AML (age 60+) in Good Health	Hand Grip Strength Test	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.
Healthy Control Group: Adults with AML (age 60+) in Good Health	Computed Tomography Scans to Measure Skeletal Muscular Index	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.

Primary Outcome Measures

Name	Time	Method
Treatment-Related Mortality Rates Based on Incidence of Sarcopenia in All Study Participants	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.

Secondary Outcome Measures

Name	Time	Method
The prognostic impact of malnutrition and sarcopenia on treatment-related mortality rates and overall survival in study participants with AML	60 days	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.
Incidence of Malnutrition Among Participants in Group 1 Compared to Incidence of Malnutrition in Healthy Control Group	60 days	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).
Incidence of Sarcopenia Among Participants in Group 1 Compared to Incidence of Sarcopenia in Healthy Control Group	60 days	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.

Trial Locations

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States