Clinical trial NCT06277388: Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.
Official title: Hemodynamic Changes and Prognostic Analysis of Patients With Locally Advanced Non-small Cell Lung Cancer During Combined Chemoradiotherapy and Immunotherapy: An Observational Study Based on Dynamic Cardiac Output.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Cardiac Toxicity
Keywords: Non-small Cell Lung Cancer
impedance cardiography
concurrent chemoradiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced non-small cell lung cancer patients treated by neoadjuvant chemotherapy plus immune checkpoint inhibitors following definitive concurrent chemoradiotherapy.

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.


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.

Primary outcomes:
measure: Stroke volume（SV）
timeFrame: From enrollment to 2 year after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hui Liu
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, MD
role: PRINCIPAL_INVESTIGATOR
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