Using impedance cardiography to assess heart function in lung cancer patients during treatment
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.
This study tests if a special heart monitoring technique can help understand heart function changes in lung cancer patients during their treatment and see how it relates to their recovery and side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 237 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06277388 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of impedance cardiography (ICG) to evaluate hemodynamic changes in patients with locally advanced non-small cell lung cancer (LA-NSCLC) undergoing concurrent chemoradiotherapy and immunotherapy. It focuses on assessing these changes during a 6-minute walk test and aims to analyze how cardiac parameters can predict treatment toxicity and survival outcomes. The observational nature of the study allows for the collection of data without altering the treatment regimen of the participants.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with untreated, unresectable stage IIIA-IIIC non-small cell lung cancer.
Not a fit: Patients with mixed small cell and non-small cell lung cancer histology or those with a life expectancy of less than 12 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into monitoring heart function in lung cancer patients, potentially improving treatment safety and outcomes.
How similar studies have performed: While the specific use of impedance cardiography in this context may be novel, similar studies have shown promise in monitoring cardiac function during cancer treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Hui Liu — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hui Liu, MD — Sun Yat-sen University
- Study coordinator: Hui Liu, MD
- Email: liuhuisysucc@126.com
- Phone: +86-020-87343031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.