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Completed

NCT Number: NCT05458258

Studying 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioelectrical Impedence Analysis Device

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

Other

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

Diagnostic 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 Draw

Diagnostic 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 Test

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The prognostic impact of malnutrition and sarcopenia on treatment-related mortality rates and overall survival in study participants with AML

    Time frame: 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.

  2. Incidence of Malnutrition Among Participants in Group 1 Compared to Incidence of Malnutrition in Healthy Control Group

    Time frame: 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).

  3. Incidence of Sarcopenia Among Participants in Group 1 Compared to Incidence of Sarcopenia in Healthy Control Group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Investigating The Prognostic Significance Of Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2022
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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