NCT06937554

Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients

Evaluation of Physical-cognitive-functional and Nutritional Parameters in Inpatients Affected by Acute Leukemia During Intensive Chemotherapy Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This single-center observational prospective longitudinal study will assess cognitive, physical, and nutritional performance in acute leukemia patients undergoing intensive chemotherapy. Patients will provide informed consent prior to enrollment. Hematologists will oversee clinical management and approve evaluations, while physical and rehabilitation medicine specialists and a nutritionist will conduct assessments. Performance will be evaluated at admission, discharge, and three weeks (21 days) after starting chemotherapy.

Detailed description

This is an observational prospective longitudinal single-center study. All patients will be required to agree to participate in the study and to sign an informed consent prior to enrollment. During the course of the study, the hematologists will manage the patients as per clinical practice and give clearance to perform each evaluation. All functional assessments and tests will be carried out by trained healthcare personnel with experience in the field of rehabilitation (either a Physical and Rehabilitation Medicine Resident, a Specialist, or a physiotherapist). A nutritionist will take care of assessing the nutritional aspects. The aim of this study is to analyze the cognitive, physical and nutritional performance of AL patients hospitalized to receive intensive chemiotherapy (IC). Each item will be assessed at admission and discharge from the ward and after three weeks from the start of chemotherapy. Modifications of the considered items will be annotated and compared throughout the courses of chemotherapy, as well as relationship with indices of response and survival (Disease Free Survival, Overall Survival) will be explored. Such an effort will help further understanding how hematologic inpatients perform during IC treatment and what are the consequences on their quality of life and activities of daily living.

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
OTHER	observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters	observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters

Timeline

• Start date: 2025-04-10
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-04-22
• Last updated: 2025-04-22

Locations

1 site across 1 country: Italy