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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

239

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

July 11, 2022

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed

8 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed

Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

July 11, 2022

Last Update Submit

April 25, 2025

Conditions

Acute Myeloid Leukemia Leukemia, Myeloid

Keywords

AML

Outcome Measures

Primary Outcomes (1)

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.
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
60 days
Incidence of Malnutrition Among Participants in Group 1 Compared to Incidence of Malnutrition in Healthy Control Group
60 days
Incidence of Sarcopenia Among Participants in Group 1 Compared to Incidence of Sarcopenia in Healthy Control Group
60 days

Study Arms (2)

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.

Device: Bioelectrical Impedence Analysis DeviceOther: 6 Minute Walk TestDiagnostic Test: Computed Tomography Scans to Measure Skeletal Muscular IndexDiagnostic Test: Blood Test/Blood DrawOther: 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.

Interventions

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.