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Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery (B-BIT)

2026년 5월 12일 업데이트: Chang-Ik Yoon

A Pragmatic Clinical Trial to Evaluate the Impact of Clinical Propranolol Strategies on Myocardial Injury After Non-cardiac Surgery (MINS) in Patients Undergoing Breast Cancer Surgery With Hypertension or Angina

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.

연구 개요

상세 설명

Breast cancer is the most common malignancy among women in Korea. Perioperative stress and acute physiological stimuli from surgery and anesthesia increase catecholamine secretion, which can lead to Myocardial Injury after Non-cardiac Surgery (MINS). Propranolol is known to stabilize hemodynamic variability by inhibiting sympathetic surge and reducing myocardial oxygen consumption. Recent studies also suggest that beta-blockers may influence the tumor microenvironment (TME) by reducing inflammation and regulating immune cell composition.This prospective, randomized, open-label, single-center pragmatic clinical trial will enroll 100 female patients (aged 20-70) with stage I-III breast cancer and comorbid hypertension or angina. Participants will be randomized 1:1 into two groups:

  1. Propranolol Group: Patients receive propranolol for at least 14 days before surgery.
  2. Non-Propranolol Group: Patients receive usual care without propranolol.The primary objective is to compare the incidence of MINS based on high-sensitivity Troponin T (hs-TnT) levels measured postoperatively. Exploratory objectives include analyzing markers of inflammation (CRP, LDH), tumor proliferation (Ki-67), and tumor-infiltrating lymphocytes (TILs) using blood and tissue samples naturally obtained during the clinical process. Long-term follow-up will be conducted for up to 5 years to evaluate recurrence and survival outcomes.

연구 유형

중재적

등록 (추정된)

100

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Chang Ik Yoon, MD, Ph.D.
  • 전화번호: 82-10-8774-0103
  • 이메일: fayn@daum.net

연구 장소

    • Seoul
      • Seoul, Seoul, 대한민국, 06591
        • Seoul St. Mary's Hospital, The Catholic University of Korea
        • 연락하다:
        • 연락하다:
          • Chang Ik Yoon, MD, Ph.D.
          • 전화번호: 82-10-8774-0103
          • 이메일: fayn@daum.net

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Female patients aged 20 to 70 years.
  2. Patients diagnosed with hypertension or angina who require medication.
  3. Patients diagnosed with unilateral, resectable primary breast cancer (ICD-10: C50), Stage I-III.
  4. ECOG performance status of 0-1.
  5. Patients scheduled to receive standard postoperative treatment (including adjuvant radiotherapy
  6. Patients who voluntarily decide to participate and sign the written informed consent form

Exclusion Criteria:

  1. Patients with distant metastases.
  2. Patients with active infectious diseases, autoimmune diseases (including specific rheumatic diseases), coagulation disorders, or cardiovascular diseases other than hypertension or angina pectoris.
  3. Patients with clinically significant hepatic, hematologic, or renal dysfunction, defined as any of the following:

    ① ANC <1,500/mm3

    • Platelets <100,000/mm3

      • Hb <9 g/dL

        • AST and ALT > 2.5 x upper limit of normal (ULN) ⑤ Alkaline phosphatase > 2.5 x ULN ⑥ Total bilirubin > 1 x ULN ⑦ Serum creatinine >1.5 x ULN or estimated creatinine clearance < 60 mL/min (as calculated using the method standard for the institution)
  4. Patients with moderate to severe asthma or chronic obstructive pulmonary disease (COPD).
  5. Patients who are pregnant or breastfeeding at the time of enrollment.
  6. Patients with a history of malignancy within the past 5 years.
  7. Patients for whom data collection is considered difficult at the discretion of the investigator.
  8. Patients who are unable to understand or complete study questionnaires.
  9. Patients who have received β-blockers within 30 days prior to screening.
  10. Patients with systolic blood pressure < 100 mmHg or heart rate < 55 beats per minute.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Propranolol Group
Participants with hypertension or angina undergoing breast cancer surgery will receive Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
활성 비교기: Non-Propranolol Group (Usual Care)
Participants will receive standard clinical care for hypertension or angina without the use of Propranolol or other beta-blockers before surgery
Standard medical management (e.g., CCB, ACEi, ARB, or diuretics) at the physician's discretion, excluding beta-blockers.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
기간: From the day of surgery (Day 0) up to 30 days postoperatively

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

2차 결과 측정

결과 측정
측정값 설명
기간
Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation
기간: During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
Comparison of the fluctuation range of blood pressure during surgery and in the recovery room (up to 2hours post-surgery)
During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
Perioperative Hemodynamic Stability: Heart rate Fluctuation
기간: During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
Comparison of the fluctuation range of Heart rate during surgery and in the recovery room (up to 2hours post-surgery)
During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
Postoperative Cardiovascular and Respiratory Complications Rate
기간: Within 30 days after surgery
Incidence of major cardiovascular and respiratory complications, including MI, CVA, MINS, and pulmonary complications.
Within 30 days after surgery
length of hospital stay
기간: Within 30 days after surgery
Total number of days from the date of surgery to the date of discharge.
Within 30 days after surgery
Change in Patient-Reported Anxiety (HADS-A)
기간: Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery
Evaluation of the change in anxiety levels using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale. The score ranges from 0 to 21, with higher scores indicating higher anxiety.
Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery

기타 결과 측정

결과 측정
측정값 설명
기간
Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index
기간: At the time of surgery (Day 0)
The percentage of Ki-67 positive tumor cells measured by immunohistochemistry in surgical tissues.
At the time of surgery (Day 0)
Tumor Microenvironment and Biological Markers: Histological Grade
기간: At the time of surgery (Day 0)
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.
At the time of surgery (Day 0)
Tumor Microenvironment and Biological Markers: Presence of Lymphovascular Invasion
기간: At the time of surgery (Day 0)
Pathological assessment of the presence or absence of tumor cells within lymphatic or vascular channels in the surgical specimen.
At the time of surgery (Day 0)
Tumor Microenvironment and Biological Markers: Tumor-Infiltrating Lymphocytes (TILs)
기간: At the time of surgery (Day 0)
Percentage of stromal area occupied by mononuclear inflammatory cells in the surgical specimen.
At the time of surgery (Day 0)
Changes in Inflammatory Markers and Serum Tumor Markers: C-Reactive Protein (CRP)
기간: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Comparison of changes in C-reactive protein (CRP)
Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Changes in Inflammatory Markers and Serum Tumor Markers: lactate dehydrogenase (LDH)
기간: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Comparison of changes in lactate dehydrogenase (LDH)
Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Changes in Inflammatory Markers and Serum Tumor Markers: Carcinoembryonic Antigen (CEA)
기간: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Comparison of changes in serum tumor marker CEA
Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Changes in Inflammatory Markers and Serum Tumor Markers: Cancer Antigen 15-3 (CA 15-3)
기간: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Comparison of changes in serum tumor markers CA 15-3
Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Long-term Recurrence and Survival Outcomes
기간: Up to 5 years after surgery
Descriptive analysis of recurrence status, invasive disease-free survival (iDFS), and overall survival (OS)
Up to 5 years after surgery
Molecular and Immunological Analysis
기간: Up to 5 years (duration of sample storage and analysis)
Exploration of biological changes related to propranolol use through molecular analysis (e.g., RNA/DNA sequencing) using stored tissue and blood samples.
Up to 5 years (duration of sample storage and analysis)

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스폰서

수사관

  • 수석 연구원: Chang Ik Yoon, MD, Ph.D., Seoul St. Mary's Hospital, The Catholic University of Korea

간행물 및 유용한 링크

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일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

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기본 완료 (추정된)

2028년 5월 23일

연구 완료 (추정된)

2033년 5월 24일

연구 등록 날짜

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처음 게시됨 (실제)

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유방암에 대한 임상 시험

propranolol에 대한 임상 시험

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