Impact of Neoadjuvant Chemotherapy on Heart Function in Breast Cancer Patients

Effect of Neoadjuvant Chemotherapy on Cardiac Function of Perioperative Patients With Breast Cancer and New Strategies for Anesthesia Response: a Multicenter, Prospective, Randomized, Controlled Study

This study tests how chemotherapy before breast cancer surgery affects heart function and looks for ways to keep the heart stable during treatment.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 496 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06497660 on ClinicalTrials.gov

What this trial studies

This study investigates how neoadjuvant chemotherapy affects cardiac function in patients undergoing surgery for breast cancer. It aims to assess the perioperative cardiac complications associated with anesthesia and develop improved anesthesia strategies to mitigate these effects. The research will involve monitoring patients' heart function before and after chemotherapy and during the perioperative period. The study will utilize interventions such as deoxyadrenaline and normal saline to evaluate their impact on cardiac stability.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a left ventricular ejection fraction of at least 45% before chemotherapy.

Not a fit: Patients with significant pre-existing heart conditions or severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer anesthesia practices and improved cardiac outcomes for breast cancer patients undergoing surgery.

How similar studies have performed: While there is ongoing research in this area, the specific focus on neoadjuvant chemotherapy's impact on cardiac function during the perioperative period is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 and above;
2. Left ventricular ejection fraction shall not be less than 45% before neoadjuvant chemotherapy and not less than 40% after neoadjuvant chemotherapy;
3. The electrocardiogram shows sinus rhythm;
4. Acetylsalicylic acidlevel I to III;
5. Can understand and cooperate with the research process.

Exclusion Criteria:

1. Patients with congenital organic heart disease, arrhythmia requiring intervention, heart valve disease, cardiomyopathy, high atrioventricular and bundle branch block, history of myocardial infarction, severe hypertension, long-term diabetes and other diseases affecting heart function;
2. Patients with severe dysfunction of important organs such as liver and kidney, who are intolerant to neoadjuvant chemotherapy or surgical anesthesia;
3. Patients who are allergic to the drugs used in this study;
4. Patients with mental illness, consciousness disorders, and communication barriers;
5. Patients with severe coagulation dysfunction;
6. Patients who have used monoamine oxidase inhibitors within two weeks prior to anesthesia surgery;
7. Patients who refused to participate in this study.

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Affiliated Union Hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Zhongmeng LZM Lai, Doctor of Medicine

Conditions: Breast Cancer, Neoadjuvant Chemotherapy, Perioperative Period, Anaesthesia, Cardiac Function