Cardiovascular intervention for 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.

This study is testing if early heart care can help lung cancer patients avoid heart problems while they are getting treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 524 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04980716 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of early cardiovascular intervention using impedance cardiography in patients with locally advanced non-small cell lung cancer undergoing radical radiochemotherapy and possibly immunotherapy. Participants are randomly assigned to either an intervention group, which receives cardiovascular evaluations and treatments at multiple timepoints, or a control group, which is monitored without intervention unless severe cardiovascular events occur. The study aims to assess the impact of these interventions on cardiovascular complications during and after cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced, unresectable non-small cell lung cancer who are scheduled for radical radiotherapy and chemotherapy.

Not a fit: Patients with early-stage lung cancer or those who are not candidates for radical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce cardiovascular complications in lung cancer patients undergoing aggressive treatment.

How similar studies have performed: While there have been studies on cardiovascular interventions in cancer patients, this specific approach using impedance cardiography is relatively novel.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Hui Liu, Professor — Sun yat-sen universtiy cancer center
• Study coordinator: Bo Qiu

Conditions: Non-small Cell Lung Cancer, Cardiovascular Complication, Cardiovascular Intervention, Impedance Cardiography, Cardiovascular Event