Studying Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia

The University of Chicago

Status: Completed

Conditions: Leukemia, Myeloid; Acute Myeloid Leukemia

Treatments: Other: 6 Minute Walk Test; Diagnostic Test: Blood Test/Blood Draw; Device: Bioelectrical Impedence Analysis Device; Diagnostic Test: Computed Tomography Scans to Measure Skeletal Muscular Index; Other: Hand Grip Strength Test

Study type: Observational

Funder types: Other

Identifiers

NCT05458258

IRB22-0397

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

239 participants in 2 patient groups

Adults (age 60+) with Newly Diagnosed AML

Description:

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.

Treatment:

Other: Hand Grip Strength Test

Diagnostic Test: Computed Tomography Scans to Measure Skeletal Muscular Index

Device: Bioelectrical Impedence Analysis Device

Diagnostic Test: Blood Test/Blood Draw

Other: 6 Minute Walk Test

Healthy Control Group: Adults with AML (age 60+) in Good Health

Description:

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.

Treatment:

Other: Hand Grip Strength Test

Diagnostic Test: Computed Tomography Scans to Measure Skeletal Muscular Index

Device: Bioelectrical Impedence Analysis Device

Diagnostic Test: Blood Test/Blood Draw

Other: 6 Minute Walk Test