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Trial Title:
Effect of Neoadjuvant Chemotherapy on Cardiac Function of Perioperative Patients With Breast Cancer and New Strategies for Anesthesia
NCT ID:
NCT06497660
Condition:
Breast Cancer
Neoadjuvant Chemotherapy
Perioperative Period
Anaesthesia
Cardiac Function
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Deoxyadrenaline
Description:
Deoxyadrenaline is a vasoactive drug
Arm group label:
Anthracene ring drug α group
Arm group label:
Carboplatin drug α group
Arm group label:
Combined use α group
Arm group label:
control α group
Intervention type:
Drug
Intervention name:
normal saline
Description:
Deoxyadrenaline is a vasoactive drug
Arm group label:
Anthracene ring drug β group
Arm group label:
Carboplatin drug β group
Arm group label:
Combined use β group
Arm group label:
control β group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Source:
Fujian Medical University Union Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06497660
