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

Non-small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277388
• Other study ID #: GASTO-10108
• Status: Recruiting
• Start date: June 5, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Sun Yat-sen University
• Contact: Hui Liu, MD
• Phone: +86-020-87343031
• Email: liuhuisysucc[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 237
• Est. completion date: July 1, 2024
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Cardiac Toxicity
• Cardiotoxicity
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Device:
• 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).

Locations

Country	Name	City	State
China	Hui Liu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke volume(SV)	The volume of blood ejected from the left ventricle of the heart in one contraction or heartbeat.	From enrollment to 2 year after radiotherapy