Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients

Launched by SUN YAT-SEN UNIVERSITY · Jul 24, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether early heart care can help patients with locally advanced non-small cell lung cancer who are undergoing treatment with radiation and chemotherapy, and possibly immunotherapy. Researchers will use a specific method called impedance cardiography to assess heart function and determine if starting heart treatment early can improve overall outcomes for these patients.

To participate, individuals must be between 18 and 75 years old, diagnosed with locally advanced non-small cell lung cancer, and planning to undergo aggressive treatment. They should also be generally healthy, with good heart and organ function, and have a life expectancy of at least 12 weeks. Participants will receive specialized heart care alongside their cancer treatment and will be monitored closely throughout the trial. Before joining, they will need to provide informed consent, ensuring they understand the study and its procedures. This trial is currently recruiting participants, and it's important for potential volunteers to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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;
• • 2. Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;
• • 3. Male or female between 18 and 75 years old;
• • 4. Life expectancy ≥ 12 weeks;
• • 5. The World Health Organization (WHO) PS score is 0 or 1;
• • 6. 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;
• • 7. A signed informed consent form is required before proceeding with any step in the research;
• • 8. There is an abnormality in the initial cardiac output index.
• Exclusion Criteria:
• • 1. PS score 2-4;
• • 2. 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;
• • 3. Unstable angina or myocardial infarction occurred in the past month;
• • 4. Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
• • 5. Active endocarditis;
• • 6. Symptomatic severe aortic stenosis;
• • 7. Heart failure that has not been controlled;
• • 8. Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
• • 9. Suspected or confirmed aortic dissection;
• • 10. Uncontrolled bronchial asthma;
• • 11. Pulmonary edema;
• • 12. Fingertip blood oxygen saturation at rest ≤85%;
• • 13. Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise;
• • 14. Mental disorders make it impossible to cooperate.
• • 15. Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.