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

Recruiting

• Conditions: Cardiac Toxicity; Non-small Cell Lung Cancer
• Interventions: Device: Impedance cardiography

• Registration Number: NCT06277388
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-05
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-29
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-06-05
• Study Completion: 2025-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 237

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Impedance cardiography(ICG)	Impedance cardiography	The ICG during 6MWT was performed before induction chemo-immunotherapy, before CCRT, and before consolidative immunotherapy for patients with locally advanced NSCLC.

Primary Outcome Measures

Name	Time	Method
Stroke volume（SV）	From enrollment to 2 year after radiotherapy	The volume of blood ejected from the left ventricle of the heart in one contraction or heartbeat.

Trial Locations

Locations (1)

Hui Liu; 🇨🇳 Guangzhou, Guangdong, China