Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.
NCT ID: NCT06277388
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
237 participants
OBSERVATIONAL
2021-06-05
2025-06-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Impedance cardiography(ICG)
The ICG during 6MWT was performed before induction chemo-immunotherapy, before CCRT, and before consolidative immunotherapy for patients with locally advanced NSCLC.
Impedance cardiography
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).
Interventions
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Impedance cardiography
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).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Hui Liu
Clinical Professor
Principal Investigators
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Hui Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Hui Liu
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Hui Liu, MD
Role: primary
References
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Wang 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.
Dess 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.
Atkins 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.
Wang 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.
Lang 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.
Lang 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.
Janssen-Heijnen ML, Schipper RM, Razenberg PP, Crommelin MA, Coebergh JW. Prevalence of co-morbidity in lung cancer patients and its relationship with treatment: a population-based study. Lung Cancer. 1998 Aug;21(2):105-13. doi: 10.1016/s0169-5002(98)00039-7.
Other Identifiers
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GASTO-10108
Identifier Type: -
Identifier Source: org_study_id