Effect of Neoadjuvant Chemotherapy on Cardiac Function of Perioperative Patients With Breast Cancer and New Strategies for Anesthesia

NCT ID: NCT06497660

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 496 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-31

Brief Summary

As is well known, perioperative hemodynamic fluctuations, such as decreased blood pressure and heart rate, and cardiac dysfunction, are common complications after anesthesia. General anesthetics such as propofol and sufentanil can inhibit the central nervous system, reduce cardiac excitability and myocardial contractility, dilate peripheral blood vessels, and have a high incidence of hypotension, especially during anesthesia induction, which is particularly common in the elderly and those with underlying underlying diseases before surgery.

However, the current research on the impact of neoadjuvant chemotherapy on perioperative cardiac function in patients is not specific, and there is no unified anesthesia strategy for these effects during the perioperative period. Therefore, this study aims to explore: 1. the effect of neoadjuvant chemotherapy on perioperative cardiac function in patients; 2. Improve the anesthesia plan and further explore new strategies for perioperative organ protection for such patients. The research design is a prospective, randomized, controlled trial.

Detailed Description

Traditional chemotherapy is a common treatment for cancer, usually performed after surgery, with the aim of assisting in the removal of remaining cancer cells. Nausea, vomiting, fatigue, hair loss, bone marrow suppression, and other common complications can even affect the function of important organs such as the heart, lungs, and brain. In the 1980s, with the reflection on traditional chemotherapy and further understanding of tumor biology, clinical trials and research began to focus on a method of neoadjuvant chemotherapy that combines surgical resection before surgery.

Neoadjuvant chemotherapy refers to the systemic chemotherapy performed before implementing local treatment methods (such as surgery), with the aim of reducing the size of the tumor, killing invisible metastatic cells early, and reducing adverse reactions to traditional chemotherapy [6], which is a new chemotherapy method that is beneficial for subsequent surgery, radiotherapy, and other treatments. However, it should be noted that neoadjuvant chemotherapy may still cause a certain degree of cardiac dysfunction.

As is well known, perioperative hemodynamic fluctuations, such as decreased blood pressure and heart rate, and cardiac dysfunction, are common complications after anesthesia. General anesthetics such as propofol and sufentanil can inhibit the central nervous system, reduce cardiac excitability and myocardial contractility, dilate peripheral blood vessels, and have a high incidence of hypotension, especially during anesthesia induction, which is particularly common in the elderly and those with underlying underlying diseases before surgery.

In summary, after completing neoadjuvant chemotherapy, the patient's physical and mental functions are affected to a certain extent. If combined with the effects of anesthetic drugs, the hemodynamic fluctuations are greater than those of the general population, which may further cause cardiac dysfunction and is worthy of attention. However, the current research on the impact of neoadjuvant chemotherapy on perioperative cardiac function in patients is not specific, and there is no unified anesthesia strategy for these effects during the perioperative period. Therefore, this study aims to explore: 1. the effect of neoadjuvant chemotherapy on perioperative cardiac function in patients; 2. Improve the anesthesia plan and further explore new strategies for perioperative organ protection for such patients. The research design is a prospective, randomized, controlled trial.

Conditions

Breast Cancer; Neoadjuvant Chemotherapy; Perioperative Period; Anaesthesia; Cardiac Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A α group

Breast cancer patients with neoadjuvant chemotherapy scheme of "EC-T" and selective surgery were selected, and they were intervened with norepinephrine during the perioperative period.

Group Type: EXPERIMENTAL

Deoxyadrenaline

Intervention Type: DRUG

Deoxyadrenaline is a vasoactive drug

B α group

Breast cancer patients with "TCb" neoadjuvant chemotherapy and elective surgery were selected, and they were intervened with norepinephrine during the perioperative period

Group Type: EXPERIMENTAL

Deoxyadrenaline

Intervention Type: DRUG

Deoxyadrenaline is a vasoactive drug

C α group

Breast cancer patients with "TCbHP" neoadjuvant chemotherapy and elective surgery were selected, and they were intervened with norepinephrine during the perioperative period.

Group Type: EXPERIMENTAL

Deoxyadrenaline

Intervention Type: DRUG

Deoxyadrenaline is a vasoactive drug

control α group

Patients with breast cancer who have not received neoadjuvant chemotherapy and who have undergone elective surgery, and who have received perioperative intervention with norepinephrine.

Group Type: PLACEBO_COMPARATOR

Deoxyadrenaline

Intervention Type: DRUG

Deoxyadrenaline is a vasoactive drug

A β group

Select breast cancer patients with neoadjuvant chemotherapy scheme of "EC-T" and elective surgery, and use normal saline for control during perioperative period.

Group Type: EXPERIMENTAL

normal saline

Intervention Type: DRUG

Deoxyadrenaline is a vasoactive drug

B β group

Breast cancer patients with "TCb" neoadjuvant chemotherapy and elective surgery were selected, and physiological saline was used as control during perioperative period.

Group Type: EXPERIMENTAL

normal saline

Intervention Type: DRUG

Deoxyadrenaline is a vasoactive drug

C β group

Breast cancer patients with "TCbHP" neoadjuvant chemotherapy and elective surgery were selected, and physiological saline was used as control during perioperative period.

Group Type: EXPERIMENTAL

normal saline

Intervention Type: DRUG

Deoxyadrenaline is a vasoactive drug

control β group

Breast cancer patients who have not received neoadjuvant chemotherapy and who have undergone elective surgery, and who use normal saline control during the perioperative period.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

Deoxyadrenaline is a vasoactive drug

Interventions

Deoxyadrenaline

Deoxyadrenaline is a vasoactive drug

Intervention Type: DRUG

normal saline

Deoxyadrenaline is a vasoactive drug

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Medical University Affiliated Union Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhongmeng LZM Lai, Doctor of Medicine

Role: CONTACT

angerer1980@163.com

13395000771

Rongjian LRJ Li, Bachelor of Medicine

Role: CONTACT

1216254452@qq.com

13328595626

Facility Contacts

Lai Zhongmeng

Role: primary

13395000771

Other Identifiers

LZMLRJXFZHLRXAYJ

Identifier Type: -

Identifier Source: org_study_id