Studying Malnutrition And Sarcopenia In Older Adults With Acute Myeloid Leukemia
- Conditions
- Leukemia, MyeloidAcute Myeloid Leukemia
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
- 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
- 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
- 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
University of Chicago Medicine Comprehensive Cancer Center🇺🇸Chicago, Illinois, United States