Clinical trial · Observational
Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.
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.
NCT06277388CI-TRIAL-00105257active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Toxicity | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Impedance cardiography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Impedance cardiography(ICG)
- description
- The ICG during 6MWT was performed before induction chemo-immunotherapy, before CCRT, and before consolidative immunotherapy for patients with locally advanced NSCLC.
- interventionNames
- Device: Impedance cardiography
Primary outcomes (1)
- measure
- Stroke volume（SV）
- timeFrame
- From enrollment to 2 year after radiotherapy
- description
- The volume of blood ejected from the left ventricle of the heart in one contraction or heartbeat.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDWang H, Wei J, Zheng Q, Meng L, Xin Y, Yin X, Jiang X. Radiation-induced heart disease: a review of classification, mechanism and prevention. Int J Biol Sci. 2019 Aug 8;15(10):2128-2138. doi: 10.7150/ijbs.35460. eCollection 2019. PMID 31592122
- BACKGROUNDDess RT, Sun Y, Matuszak MM, Sun G, Soni PD, Bazzi L, Murthy VL, Hearn JWD, Kong FM, Kalemkerian GP, Hayman JA, Ten Haken RK, Lawrence TS, Schipper MJ, Jolly S. Cardiac Events After Radiation Therapy: Combined Analysis of Prospective Multicenter Trials for Locally Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2017 May 1;35(13):1395-1402. doi: 10.1200/JCO.2016.71.6142. Epub 2017 Mar 16. PMID 28301264
- BACKGROUNDAtkins KM, Rawal B, Chaunzwa TL, Lamba N, Bitterman DS, Williams CL, Kozono DE, Baldini EH, Chen AB, Nguyen PL, D'Amico AV, Nohria A, Hoffmann U, Aerts HJWL, Mak RH. Cardiac Radiation Dose, Cardiac Disease, and Mortality in Patients With Lung Cancer. J Am Coll Cardiol. 2019 Jun 18;73(23):2976-2987. doi: 10.1016/j.jacc.2019.03.500. PMID 31196455
- BACKGROUNDWang K, Eblan MJ, Deal AM, Lipner M, Zagar TM, Wang Y, Mavroidis P, Lee CB, Jensen BC, Rosenman JG, Socinski MA, Stinchcombe TE, Marks LB. Cardiac Toxicity After Radiotherapy for Stage III Non-Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy. J Clin Oncol. 2017 May 1;35(13):1387-1394. doi: 10.1200/JCO.2016.70.0229. Epub 2017 Jan 23. PMID 28113017
- BACKGROUNDLang CC, Agostoni P, Mancini DM. Prognostic significance and measurement of exercise-derived hemodynamic variables in patients with heart failure. J Card Fail. 2007 Oct;13(8):672-9. doi: 10.1016/j.cardfail.2007.05.004. PMID 17923361
- BACKGROUNDLang CC, Karlin P, Haythe J, Lim TK, Mancini DM. Peak cardiac power output, measured noninvasively, is a powerful predictor of outcome in chronic heart failure. Circ Heart Fail. 2009 Jan;2(1):33-8. doi: 10.1161/CIRCHEARTFAILURE.108.798611.