Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients
Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients Who Receiving Radical Concurrent Chemoradiotherapy and Immunotherapy: a Prospective, Randomized Controlled, Multicenter Phase III Clinical Trial.
Sun Yat-sen University
524 participants
Jun 1, 2021
INTERVENTIONAL
Conditions
Summary
This is a prospective, randomized, controlled, multi-center phase III clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy.
Eligibility
Inclusion Criteria8
- It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging;
- Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;
- Male or female between 18 and 75 years old;
- Life expectancy ≥ 12 weeks;
- The World Health Organization (WHO) PS score is 0 or 1;
- Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN;
- A signed informed consent form is required before proceeding with any step in the research;
- There is an abnormality in the initial cardiac output index.
Exclusion Criteria15
- PS score 2-4;
- Organ function impairment: FEV1 \<1000ml; absolute neutrophil count \<1.5×10\^9/L; platelets \<100×10\^9/L; hemoglobin \<90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula \<50 mL/min; serum bilirubin\>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase\>2.5 times ULN;
- Unstable angina or myocardial infarction occurred in the past month;
- Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
- Active endocarditis;
- Symptomatic severe aortic stenosis;
- Heart failure that has not been controlled;
- Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
- Suspected or confirmed aortic dissection;
- Uncontrolled bronchial asthma;
- Pulmonary edema;
- Fingertip blood oxygen saturation at rest ≤85%;
- Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise;
- Mental disorders make it impossible to cooperate.
- Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.
Interventions
Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04980716