Investigating The Prognostic Significance Of Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- University of Chicago
- Enrollment
- 239
- Locations
- 1
- Primary Endpoint
- Treatment-Related Mortality Rates Based on Incidence of Sarcopenia in All Study Participants
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- 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)