Active — Not RecruitingNot Applicable

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

China231 participantsStarted 2021-06-05

Plain-language summary

This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent combined concurrent chemoradiotherapy (CCRT) and immunotherapy. Additionally, It sought to analyze the predictive significance of cardiac parameters to both treatment toxicity and survival prognosis.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. had untreated histologically or cytologically confirmed NSCLC
✓. be between the age of 18 and 75
✓. had unresectable stage IIIA-IIIC disease, as defined by the AJCC 8th edition staging system
✓. had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0\~1
✓. 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)
✓. had a forced expiratory volume in 1 second (FEV1) of ≥0.8L.

Exclusion criteria

✕. mixed small cell and NSCLC histology
✕. life expectancy lower than 12 weeks
✕. history of another primary malignancy
✕. poorly controlled intercurrent illness
✕. female in pregnancy or breast-feeding and any situation not suitable for this study judged by researchers
✕. 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.

What they're measuring

Stroke volume（SV）

Timeframe: From enrollment to 2 year after radiotherapy

Trial details

NCT IDNCT06277388

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Non-small Cell Lung Cancer trials