Breast CancerPhase 4NCT06497660
Effect of Neoadjuvant Chemotherapy on Cardiac Function of Perioperative Patients With Breast Cancer and New Strategies for Anesthesia
A Phase 4 study testing Deoxyadrenaline and normal saline in people with Breast Cancer and Neoadjuvant Chemotherapy, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Neoadjuvant Chemotherapy, Perioperative Period
- What is being tested?
- Deoxyadrenaline and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 496 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and above;
- Left ventricular ejection fraction shall not be less than 45% before neoadjuvant chemotherapy and not less than 40% after neoadjuvant chemotherapy;
- The electrocardiogram shows sinus rhythm;
- Acetylsalicylic acidlevel I to III;
- Can understand and cooperate with the research process.
Who cannot join
- 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;
- Patients with severe dysfunction of important organs such as liver and kidney, who are intolerant to neoadjuvant chemotherapy or surgical anesthesia;
- Patients who are allergic to the drugs used in this study;
- Patients with mental illness, consciousness disorders, and communication barriers;
- Patients with severe coagulation dysfunction;
- Patients who have used monoamine oxidase inhibitors within two weeks prior to anesthesia surgery;
- Patients who refused to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Affiliated Union Hospital
Fuzhou, Fujian, 350001
Lai Zhongmeng, 13395000771
About this study
Official title: 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
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.
Read the 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
- Being tested
- Deoxyadrenaline, normal saline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeoxyadrenalineDrug
Deoxyadrenaline is a vasoactive drug
normal salineDrug
Deoxyadrenaline is a vasoactive drug
| Study group | Role | What they receive |
|---|---|---|
| A α group | Experimental | 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. Receives: Drug: Deoxyadrenaline |
| B α group | Experimental | Breast cancer patients with "TCb" neoadjuvant chemotherapy and elective surgery were selected, and they were intervened with norepinephrine during the perioperative period Receives: Drug: Deoxyadrenaline |
| C α group | Experimental | Breast cancer patients with "TCbHP" neoadjuvant chemotherapy and elective surgery were selected, and they were intervened with norepinephrine during the perioperative period. Receives: Drug: Deoxyadrenaline |
| control α group | Placebo comparator | Patients with breast cancer who have not received neoadjuvant chemotherapy and who have undergone elective surgery, and who have received perioperative intervention with norepinephrine. Receives: Drug: Deoxyadrenaline |
| A β group | Experimental | Select breast cancer patients with neoadjuvant chemotherapy scheme of "EC-T" and elective surgery, and use normal saline for control during perioperative period. Receives: Drug: normal saline |
| B β group | Experimental | Breast cancer patients with "TCb" neoadjuvant chemotherapy and elective surgery were selected, and physiological saline was used as control during perioperative period. Receives: Drug: normal saline |
| C β group | Experimental | Breast cancer patients with "TCbHP" neoadjuvant chemotherapy and elective surgery were selected, and physiological saline was used as control during perioperative period. Receives: Drug: normal saline |
| control β group | Placebo comparator | 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. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of blood pressure decrease during anesthesia induction
Compare the blood pressure changes of patients after entering the operating room and undergoing anesthesia induced tracheal intubation.（Unit in mmHg）
Measured: On the day of surgery, compare the blood pressure changes of patients after entering the operating room and anesthesia induced tracheal intubation, with a maximum of 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Aug 2024
- Primary completion2 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497660
- Sponsor's protocol ID
- LZMLRJXFZHLRXAYJ
- Status last verified
- Mar 2024
- First submitted
- 5 May 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06497660
- Acronym / sponsor ID
- LZMLRJXFZHLRXAYJ
- Conditions
- Breast Cancer, Neoadjuvant Chemotherapy, Perioperative Period, Anaesthesia, Cardiac Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 2 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A α group | Experimental | Drug: DeoxyadrenalineBreast cancer patients with neoadjuvant chemotherapy scheme of "EC-T" and selective surgery were selected, and they were intervened with norepinephrine during the perioperative period. |
| B α group | Experimental | Drug: DeoxyadrenalineBreast cancer patients with "TCb" neoadjuvant chemotherapy and elective surgery were selected, and they were intervened with norepinephrine during the perioperative period |
| C α group | Experimental | Drug: DeoxyadrenalineBreast cancer patients with "TCbHP" neoadjuvant chemotherapy and elective surgery were selected, and they were intervened with norepinephrine during the perioperative period. |
| control α group | Placebo comparator | Drug: DeoxyadrenalinePatients with breast cancer who have not received neoadjuvant chemotherapy and who have undergone elective surgery, and who have received perioperative intervention with norepinephrine. |
| A β group | Experimental | Drug: normal salineSelect breast cancer patients with neoadjuvant chemotherapy scheme of "EC-T" and elective surgery, and use normal saline for control during perioperative period. |
| B β group | Experimental | Drug: normal salineBreast cancer patients with "TCb" neoadjuvant chemotherapy and elective surgery were selected, and physiological saline was used as control during perioperative period. |
| C β group | Experimental | Drug: normal salineBreast cancer patients with "TCbHP" neoadjuvant chemotherapy and elective surgery were selected, and physiological saline was used as control during perioperative period. |
| control β group | Placebo comparator | Drug: normal salineBreast cancer patients who have not received neoadjuvant chemotherapy and who have undergone elective surgery, and who use normal saline control during the perioperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 and above;
- Left ventricular ejection fraction shall not be less than 45% before neoadjuvant chemotherapy and not less than 40% after neoadjuvant chemotherapy;
- The electrocardiogram shows sinus rhythm;
- Acetylsalicylic acidlevel I to III;
- Can understand and cooperate with the research process.
Key exclusion criteria (7 listed)
- 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;
- Patients with severe dysfunction of important organs such as liver and kidney, who are intolerant to neoadjuvant chemotherapy or surgical anesthesia;
- Patients who are allergic to the drugs used in this study;
- Patients with mental illness, consciousness disorders, and communication barriers;
- Patients with severe coagulation dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeoxyadrenalineDeoxyadrenaline is a vasoactive drug | Drug | A α group, B α group, C α group, control α group |
| normal salineDeoxyadrenaline is a vasoactive drug | Drug | A β group, B β group, C β group, control β group |
Primary outcome
The degree of blood pressure decrease during anesthesia induction
Time frame: On the day of surgery, compare the blood pressure changes of patients after entering the operating room and anesthesia induced tracheal intubation, with a maximum of 12 months after surgery.
Compare the blood pressure changes of patients after entering the operating room and undergoing anesthesia induced tracheal intubation.（Unit in mmHg）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deoxyadrenaline and normal saline in people with Breast Cancer and Neoadjuvant Chemotherapy, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongmeng LZM Lai, Doctor of Medicine (13395000771, angerer1980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of blood pressure decrease during anesthesia induction (time frame: On the day of surgery, compare the blood pressure changes of patients after entering the operating room and anesthesia induced tracheal intubation, with a maximum of 12 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.