Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery

ConditionsBreast Cancer Myocardial Injury After Noncardiac Surgery (MINS)

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age20-70

SponsorChang-Ik Yoon

About this trial

This study aims to evaluate the impact of using propranolol, a non-selective beta-blocker, on preventing myocardial injury after non-cardiac surgery (MINS) in breast cancer patients who also have hypertension or angina. Stress from surgery and anesthesia can increase sympathetic activity and inflammation, which may lead to heart stress. This pragmatic clinical trial will compare patients who are prescribed propranolol as part of their routine care with those who are not. Researchers will analyze blood samples and surgical tissues collected during normal treatment to observe changes in heart health and the tumor microenvironment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 20 to 70 years.

Patients diagnosed with hypertension or angina who require medication.

Patients diagnosed with unilateral, resectable primary breast cancer (ICD-10: C50), Stage I-III.

ECOG performance status of 0-1.

Disqualifiers

Patients with distant metastases.

Patients with active infectious diseases, autoimmune diseases (including specific rheumatic diseases), coagulation disorders, or cardiovascular diseases other than hypertension or angina pectoris.

Platelets <100,000/mm3

Hb <9 g/dL

Trial design

Design model

Parallel

Treatments tested in this trial

propranolol
Drug
Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
Usual Care
Other intervention
Standard medical management (e.g., CCB, ACEi, ARB, or diuretics) at the physician's discretion, excluding beta-blockers.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Propranolol GroupExperimental treatment 1 intervention

Group B: Non-Propranolol Group (Usual Care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of Myocardial Injury after Noncardiac Surgery (MINS)

MINS is defined as an elevated high-sensitivity cardiac Troponin T (hs-TnT) level measured for clinical purposes after surgery that exceeds the 99th percentile upper reference limit. Specifically, it is defined as: 1. 0.02-0.065 ng/mL with an absolute change of more than 0.005ng/mL or 2. any elevation ≥0.065 ng/mL or any absolute change more than 0.014 ng/mL

Time frame

From the day of surgery (Day 0) up to 30 days postoperatively

Secondary outcomes

Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation

Comparison of the fluctuation range of blood pressure during surgery and in the recovery room (up to 2hours post-surgery)

Time frame

During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)

Perioperative Hemodynamic Stability: Heart rate Fluctuation

Comparison of the fluctuation range of Heart rate during surgery and in the recovery room (up to 2hours post-surgery)

Time frame

During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)

Postoperative Cardiovascular and Respiratory Complications Rate

Incidence of major cardiovascular and respiratory complications, including MI, CVA, MINS, and pulmonary complications.

Time frame

Within 30 days after surgery

length of hospital stay

Total number of days from the date of surgery to the date of discharge.

Time frame

Within 30 days after surgery

Other outcomes

Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index

The percentage of Ki-67 positive tumor cells measured by immunohistochemistry in surgical tissues.

Time frame

At the time of surgery (Day 0)

Tumor Microenvironment and Biological Markers: Histological Grade

Assessment of tumor differentiation using the Modified Bloom-Richardson grade. The scale ranges from 3 to 9, where higher scores indicate a more aggressive tumor/worse outcome.

Time frame

At the time of surgery (Day 0)

Tumor Microenvironment and Biological Markers: Presence of Lymphovascular Invasion

Pathological assessment of the presence or absence of tumor cells within lymphatic or vascular channels in the surgical specimen.

Time frame

At the time of surgery (Day 0)

Tumor Microenvironment and Biological Markers: Tumor-Infiltrating Lymphocytes (TILs)

Percentage of stromal area occupied by mononuclear inflammatory cells in the surgical specimen.

Time frame

At the time of surgery (Day 0)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang-Ik Yoon

Lead sponsor

Seoul St. Mary's Hospital

Sponsor institution

Seoul St. Mary's Hospital

Collaborator

Source ClinicalTrials.gov

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