Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-10

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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

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Acute Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

Intervention Type OTHER

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

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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.