Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients (FisNutEma)

University of Rome Tor Vergata

Status: Enrolling

Conditions: Acute Leukemia

Treatments: Other: observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters

Study type: Observational

Funder types: Other

Identifiers

NCT06937554

FisNutEma

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age above 18 years
• Patients affected by Acute Leukemia
• Inpatients performing intensive chemotherapy
• Patients with no restrictions on mobilization
• Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws.

Exclusion criteria

• Age <18 years
• Any medical condition that the attending doctor judges as limiting to perform study related tasks

Trial design

30 participants in 1 patient group

Patients above 18 years, affected by Acute Leukemia, performing intensive chemotherapy

Treatment:

Other: observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters