Prognostic Impacts of Lipid Profile and BMI in Adult AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AML (Acute Myeloid Leukemia), BMI, Lipid Profile, Induction Chemotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prognostic Impacts of Lipid Profile and Body Mass Index in Adult Acute Myeloid Leukemia Patients Treated With Intensive Induction Chemotherapy
Overview
The goal of this observational study is to evaluate the changes in lipid profile parameters (total cholesterol, triglycerides, HDL-C, and LDL-C) in adult AML patients before and after intensive induction chemotherapy. The main questions it aims to answer are: * Are there correlations between metabolic changes (in lipid profile and BMI) and treatment outcomes, including remission status and incidence of chemotherapy-related complications? * Can the baseline lipid profile and BMI serve as prognostic markers for response to induction chemotherapy.? Participants will be observed before and after induction chemotherapy regarding their lipid profile, and BMI, observing any correlations between the different results with any complications, and with remission status.
Detailed description
Acute Myeloid Leukemia is a heterogeneous hematological malignancy characterized by clonal proliferation and accumulation of immature myeloid cells in the bone marrow and peripheral blood. It predominantly affects adults and often requires aggressive treatment in the form of intensive induction chemotherapy, typically based on cytarabine and anthracyclines.
The metabolic state of patients with AML including their lipid profile and body mass index, can influence both the disease course and response to treatment. Chemotherapy and its associated complications-such as infections, inflammation, and nutritional deficiencies-may lead to profound alterations in lipid metabolism and body composition.
Dyslipidemia may also emerge as a side effect of supportive medications like corticosteroids or parenteral nutrition. BMI is a simple anthropometric indicator of nutritional and general health status. Both undernutrition and obesity have been linked to adverse outcomes in cancer patients, including increased treatment-related toxicity and inferior survival rates. Similarly, changes in lipid parameters-such as total cholesterol, triglycerides, HDL, and LDL-may reflect systemic inflammation or hepatic dysfunction during treatment.
Given the rising interest in the metabolic implications of chemotherapy, it becomes imperative to investigate how intensive treatment affects these parameters in AML patients. However, there is a paucity of local data, particularly in Egyptian settings such as Assiut University Hospitals, where nutritional profiles and healthcare practices may differ from global norms.
Studying the lipid profile and BMI before and after induction chemotherapy may help identify at-risk patients, guide supportive care, and contribute to personalized treatment planning. This research aims to bridge the gap by exploring these metabolic indicators in adult AML patients managed at the Hematology Department of Assiut University Hospitals.
Study tools include patients' demographics including (age, sex, residence, occupation and age at time of diagnosis), detailed clinical history and physical examination, recording of demographic data (age and gender) and disease characteristics (AML subtype). Documentation of weight and height to calculate BMI before and after induction chemotherapy. Metabolic confounders (e.g.DM and Thyroid diseases) could be ruled out by History and examination. Laboratory tests would include Complete lipid profile (total cholesterol, triglycerides, HDL-C and LDL-C) measured at baseline and after completion of induction therapy. Complete blood count (CBC), liver function tests (LFTs), renal function tests, bone marrow aspirate for AML diagnosis and monitoring, and medication received
Primary outcome measures
- Changes in lipid profile [Time frame: Pre-induction to post-induction (day 28-35).]
- Changes in Body Mass Index [Time frame: Pre-induction to post-induction (day 28-35)]
Secondary outcome measures (2)
- Association of lipid profile changes with treatment response [Time frame: Pre-induction to post-induction (day 28-35).]
- Association of Body Mass Index changes with treatment response [Time frame: Pre-induction to post-induction (day 28-35)]
Eligibility criteria
Inclusion criteria
- Adult patients (≥18yearsold) newly diagnosed with AML.
- Patients eligible for intensive induction chemotherapy.
- Patients who have given informed consent to participate in the study.
Exclusion criteria
- Patients with secondary or relapsed AML.
- Patients currently using lipid-lowering medications (e.g., statins).
- Patients with known endocrine or metabolic disorders affecting BMI or lipid profile (e.g., uncontrolled diabetes, hypothyroidism, Cushing's syndrome).
- Pregnant or lactating women.
- Patients unwilling or unable to complete the study protocol.
- Patients with M3 subtype of AML.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Assiut university Hospitals — Asyut
Identifiers
NCT: NCT07143877 · 04-2025-201323