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Trial Title:
Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.
NCT ID:
NCT06277388
Condition:
Non-small Cell Lung Cancer
Cardiac Toxicity
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cardiotoxicity
Conditions: Keywords:
Non-small Cell Lung Cancer
impedance cardiography
concurrent chemoradiotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Device
Intervention name:
Impedance cardiography
Description:
The study conducted a 6-minute walk test (6MWT) in a hospital hallway following ATS
guidelines. Patients rested for 10 minutes before the test. Impedance measurements were
taken before (2 minutes), during (6 minutes), and after (3 minutes) the walk, recording
cardio-dynamic parameters with impedance cardiography (ICG).
Arm group label:
Impedance cardiography(ICG)
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.
Criteria for eligibility:
Study pop:
Locally advanced non-small cell lung cancer patients treated by neoadjuvant chemotherapy
plus immune checkpoint inhibitors following definitive concurrent chemoradiotherapy.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hui Liu
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Liu, MD
Phone:
+86-020-87343031
Email:
liuhuisysucc@126.com
Start date:
June 5, 2021
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06277388
