Acute LeukemiaFisNutEmaNCT06937554
Evaluation of Functional and Nutritional Parameters in Fit Acute Leukemia Patients
An observational study of Acute Leukemia, run by University of Rome Tor Vergata at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2025to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Leukemia inpatients
Who may be able to join
- 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.
Who cannot join
- Age <18 years
- Any medical condition that the attending doctor judges as limiting to perform study related tasks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Tor Vergata university Hospital
Rome, RM, 00133
Nicola Manocchio, 0620908594, nicola.manocchio@uniroma2.it
About this study
Official title: Evaluation of Physical-cognitive-functional and Nutritional Parameters in Inpatients Affected by Acute Leukemia During Intensive Chemotherapy Treatment
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.
Read the 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
- Being tested
- observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters
- Keywords
- Acute leukemia, Rehabiltation, Quality of life, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parametersOther
observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters
| Study group | Role | What they receive |
|---|---|---|
| Patients above 18 years, affected by Acute Leukemia, performing intensive chemotherapy | Not described Receives: Other: observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Force Test
A grip force test using a dynamometer, also known as a handgrip dynamometer, measures how much force a person can apply with their fingers and forearms. It's a tool used to assess hand grip strength.
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Modified Borg Scale (MBS)
The MBS is a subjective rating scale used to measure the intensity of physical activity. It ranges from 6 to 20 points, with 6 representing "no exertion" and 20 representing "maximal exertion." The scale is divided into four categories: 6-9 (very light), 10-12 (light), 13-15 (somewhat hard), and 16-20 (very hard). The MBS is commonly used to assess the intensity of exercise and to monitor individual responses to physical activity. It can be used by people of all ages and fitness levels
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Tampa Scale of Kinesofobia (TSK)
Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Timed Up and Go (TUG)
Measure of function which correlates to balance and fall risk. Start timing on the word "GO" and stop timing when the subject is seated again correctly in the chair with their back resting on the back of the chair.
≤ 10 seconds
= normal
≤ 20 seconds
= good mobility, can go out alone, mobile without gait aid
≤ 30 seconds
= problems, cannot go outside alone, requires gait aid
- A score of
≥ 14 seconds has been shown to indicate high risk of falls
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Visual Analogue Scale (VAS) for pain
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Fatigue Severity Scale (FSS)
The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. A total score of less than 36 suggests that the patient may not be suffering from fatigue.
A total score of 36 or more suggests that the patient may need further evaluation by a physician.
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Functional Ambulation Classification (FAC)
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk).
A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3).
A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
SF-12 Questionnaire
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 uses eight domains:
Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Symbol Digit Modalities Test (SDMT) for processing speed
The Symbol Digit Modalities Test (SDMT) is widely used for cognitive evaluation of information processing speed, required in many cognitive operations. The person taking the test is provided with a set of symbols, each corresponding to a number. He or she is required to write down the symbols corresponding to a series of numbers within a short space of time. The SDMT is quick (~5 min) and straightforward to administer, provides a clear test score that is not influenced by subjective interpretations on the part of the healthcare professional who administers the test, and is little affected by patients׳ age, gender or educational status.
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Modified Barthel Index
The Modified Barthel Index is an ordinal scale which measures a person's ability to complete activities of daily living.
The evaluated domains are:
- Feeding
- Bathing
- Grooming
- Dressing
- Bowel
- Bladder
- Toilet use
- Transfers bed-to-chair-and-back
- Mobility on level surfaces
- Stair negotiation The higher the score, the more independent the patient is in completing the measured activity. Higher scores also indicate the patient is more likely to return home, with varying degrees of assistance, following hospital discharge.
The lower the score, the more dependent the patient is with the activity completion, and the more skilled care will be required at discharge.
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Serum pre-albumine
Serum prealbumin levels are measured using a blood test that can help assess nutritional status. Prealbumin is a protein made in the liver that helps transport thyroid hormones and vitamin A, and controls how the body uses energy. A prealbumin level below 30 mg/dL may indicate malnutrition.
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days
Serum albumine
A serum albumin test measures the amount of albumin in blood. Albumine dosage helps determining the presence of liver disease, kidney disease, or protein malabsorption. The normal range is 3.4 to 5.4 g/dL (34 to 54 g/L)
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days
Body mass index (BMI)
Body mass index (BMI) is a calculation that compares a person's weight to their height. It's a screening tool that can help determine if someone is a healthy weight for their height. BMI is calculated by dividing weight in kilograms by height in meters squared.
BMI categories:
Underweight: BMI is below 18.5 Healthy weight: BMI is between 18.5 and 24.9 Overweight: BMI is between 25 and 29.9 Obese: BMI is between 30 and 39.9 Severely obese: BMI is 40 or higher
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days
Secondary outcomes (5)
Coin test
For this test, subjects sit at a table and are timed as they pick up four coins (2€, 50cents, 10cents, 5cents ) and place them in a cup. They are required to pick up each coin individually.
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Sock test
Subjects sit in a standard chair. They are timed as putting on one sock
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Back Scratch Test
distance between the two middle fingers, one arm from above and one from below behind the back
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Forward Bending Test
distance between middle fingers and ground
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Stability test
subjects must stand on a single leg with eyes closed for the longest time possible while timed (max 30 seconds per limb).
Measured: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start10 Apr 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Manocchio, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937554
- Sponsor's protocol ID
- FisNutEma
- Acronym
- FisNutEma
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical-cognitive-functional and Nutritional Parameters in Inpatients Affected by Acute Leukemia During Intensive Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT06937554
- Acronym / sponsor ID
- FisNutEma / FisNutEma
- Conditions
- Acute Leukemia
- Keywords
- Acute leukemia, Rehabiltation, Quality of life, Nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients above 18 years, affected by Acute Leukemia, performing intensive chemotherapy | – | Other: observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Leukemia inpatients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Age <18 years
- Any medical condition that the attending doctor judges as limiting to perform study related tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational follow up aimed at evaluating functional, physical, cognitive, and nutritional parametersobservational follow up aimed at evaluating functional, physical, cognitive, and nutritional parameters | Other | Patients above 18 years, affected by Acute Leukemia, performing intensive chemotherapy |
Primary outcome
Grip Force Test
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
A grip force test using a dynamometer, also known as a handgrip dynamometer, measures how much force a person can apply with their fingers and forearms. It's a tool used to assess hand grip strength.
Modified Borg Scale (MBS)
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
The MBS is a subjective rating scale used to measure the intensity of physical activity. It ranges from 6 to 20 points, with 6 representing "no exertion" and 20 representing "maximal exertion." The scale is divided into four categories: 6-9 (very light), 10-12 (light), 13-15 (somewhat hard), and 16-20 (very hard). The MBS is commonly used to assess the intensity of exercise and to monitor individual responses to physical activity. It can be used by people of all ages and fitness levels
Tampa Scale of Kinesofobia (TSK)
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Timed Up and Go (TUG)
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Measure of function which correlates to balance and fall risk. Start timing on the word "GO" and stop timing when the subject is seated again correctly in the chair with their back resting on the back of the chair. ≤ 10 seconds = normal ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid ≤ 30 seconds = problems, cannot go outside alone, requires gait aid * A score of ≥ 14 seconds has been shown to indicate high risk of falls
Visual Analogue Scale (VAS) for pain
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Fatigue Severity Scale (FSS)
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. A total score of less than 36 suggests that the patient may not be suffering from fatigue. A total score of 36 or more suggests that the patient may need further evaluation by a physician.
Functional Ambulation Classification (FAC)
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk). A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).
SF-12 Questionnaire
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 uses eight domains: Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions
Symbol Digit Modalities Test (SDMT) for processing speed
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
The Symbol Digit Modalities Test (SDMT) is widely used for cognitive evaluation of information processing speed, required in many cognitive operations. The person taking the test is provided with a set of symbols, each corresponding to a number. He or she is required to write down the symbols corresponding to a series of numbers within a short space of time. The SDMT is quick (~5 min) and straightforward to administer, provides a clear test score that is not influenced by subjective interpretations on the part of the healthcare professional who administers the test, and is little affected by patients׳ age, gender or educational status.
Modified Barthel Index
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
The Modified Barthel Index is an ordinal scale which measures a person's ability to complete activities of daily living. The evaluated domains are: * Feeding * Bathing * Grooming * Dressing * Bowel * Bladder * Toilet use * Transfers bed-to-chair-and-back * Mobility on level surfaces * Stair negotiation The higher the score, the more independent the patient is in completing the measured activity. Higher scores also indicate the patient is more likely to return home, with varying degrees of assistance, following hospital discharge. The lower the score, the more dependent the patient is with the activity completion, and the more skilled care will be required at discharge.
Serum pre-albumine
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days
Serum prealbumin levels are measured using a blood test that can help assess nutritional status. Prealbumin is a protein made in the liver that helps transport thyroid hormones and vitamin A, and controls how the body uses energy. A prealbumin level below 30 mg/dL may indicate malnutrition.
Serum albumine
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days
A serum albumin test measures the amount of albumin in blood. Albumine dosage helps determining the presence of liver disease, kidney disease, or protein malabsorption. The normal range is 3.4 to 5.4 g/dL (34 to 54 g/L)
Body mass index (BMI)
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days
Body mass index (BMI) is a calculation that compares a person's weight to their height. It's a screening tool that can help determine if someone is a healthy weight for their height. BMI is calculated by dividing weight in kilograms by height in meters squared. BMI categories: Underweight: BMI is below 18.5 Healthy weight: BMI is between 18.5 and 24.9 Overweight: BMI is between 25 and 29.9 Obese: BMI is between 30 and 39.9 Severely obese: BMI is 40 or higher
5 secondary outcomes
Coin test
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Sock test
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Back Scratch Test
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Forward Bending Test
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Stability test
Time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia, run by University of Rome Tor Vergata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Manocchio (+390620908594, nicola.manocchio@uniroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Force Test (time frame: Initial evaluation (TO) at admission (+2 days) Intermediate evaluation (T1) at day 21 (+/- 1 day) after IC start Final evaluation (T2) at discharge (-2 days)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.