Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.

Launched by SUN YAT-SEN UNIVERSITY · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how a special test called impedance cardiography (ICG) can help doctors see changes in heart function during a short walking test in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who are receiving a combination of chemotherapy and immunotherapy. The study aims to understand how these heart measurements can predict potential treatment side effects and impact survival.

To participate in this trial, individuals should be between 18 and 75 years old, have a confirmed diagnosis of non-small cell lung cancer that cannot be surgically removed, and have a good performance status, indicating they are generally well enough to participate. Participants can expect to undergo the 6-minute walk test and have their heart function monitored, which will help researchers gather important information about the effects of their cancer treatment. It's important to note that certain health issues and conditions may exclude someone from participating, so discussing eligibility with a healthcare provider is crucial.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. had untreated histologically or cytologically confirmed NSCLC
• • 2. be between the age of 18 and 75
• • 3. had unresectable stage IIIA-IIIC disease, as defined by the AJCC 8th edition staging system
• • 4. had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0\~1
• • 5. had adequate bone marrow function (neutrophil count ≥1.5x109/L, hemoglobin concentration ≥90 g/L, platelet ≥100x109/L), kidney function (serum creatinine clearance ≥50 ml/min) and liver function (serum bilirubin ≤1.5 times upper limit of normal (ULN), aspartate transaminase (AST) and alanine transferase (ALT) ≤2.5 ULN)
• • 6. had a forced expiratory volume in 1 second (FEV1) of ≥0.8L.
• Exclusion Criteria:
• • 1. mixed small cell and NSCLC histology
• • 2. life expectancy lower than 12 weeks
• • 3. history of another primary malignancy
• • 4. poorly controlled intercurrent illness
• • 5. female in pregnancy or breast-feeding and any situation not suitable for this study judged by researchers
• • 6. patients with contraindications to 6MWT, including unstable angina pectoris or myocardial infarction within the past month, systolic blood pressure (SBP) over 180mmHg, diastolic blood pressure (DBP) over 100mmHg, muscle strength below grade 3, and severe spasm.