- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07583134
Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery (B-BIT)
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
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:
- Propranolol Group: Patients receive propranolol for at least 14 days before surgery.
- 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
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Jinah Lee, MD
- 전화번호: 82-10-8573-9324
- 이메일: jinahsmile@naver.com
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:
- Jinah Lee, MD
- 전화번호: 82-10-8573-9324
- 이메일: jinahsmile@naver.com
-
연락하다:
- Chang Ik Yoon, MD, Ph.D.
- 전화번호: 82-10-8774-0103
- 이메일: fayn@daum.net
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
- Patients scheduled to receive standard postoperative treatment (including adjuvant radiotherapy
- Patients who voluntarily decide to participate and sign the written informed consent form
Exclusion Criteria:
- 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.
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)
- Patients with moderate to severe asthma or chronic obstructive pulmonary disease (COPD).
- Patients who are pregnant or breastfeeding at the time of enrollment.
- Patients with a history of malignancy within the past 5 years.
- Patients for whom data collection is considered difficult at the discretion of the investigator.
- Patients who are unable to understand or complete study questionnaires.
- Patients who have received β-blockers within 30 days prior to screening.
- Patients with systolic blood pressure < 100 mmHg or heart rate < 55 beats per minute.
공부 계획
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:
|
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)
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Chang Ik Yoon, MD, Ph.D., Seoul St. Mary's Hospital, The Catholic University of Korea
간행물 및 유용한 링크
일반 간행물
- Botto F, Alonso-Coello P, Chan MT, Villar JC, Xavier D, Srinathan S, Guyatt G, Cruz P, Graham M, Wang CY, Berwanger O, Pearse RM, Biccard BM, Abraham V, Malaga G, Hillis GS, Rodseth RN, Cook D, Polanczyk CA, Szczeklik W, Sessler DI, Sheth T, Ackland GL, Leuwer M, Garg AX, Lemanach Y, Pettit S, Heels-Ansdell D, Luratibuse G, Walsh M, Sapsford R, Schunemann HJ, Kurz A, Thomas S, Mrkobrada M, Thabane L, Gerstein H, Paniagua P, Nagele P, Raina P, Yusuf S, Devereaux PJ, Devereaux PJ, Sessler DI, Walsh M, Guyatt G, McQueen MJ, Bhandari M, Cook D, Bosch J, Buckley N, Yusuf S, Chow CK, Hillis GS, Halliwell R, Li S, Lee VW, Mooney J, Polanczyk CA, Furtado MV, Berwanger O, Suzumura E, Santucci E, Leite K, Santo JA, Jardim CA, Cavalcanti AB, Guimaraes HP, Jacka MJ, Graham M, McAlister F, McMurtry S, Townsend D, Pannu N, Bagshaw S, Bessissow A, Bhandari M, Duceppe E, Eikelboom J, Ganame J, Hankinson J, Hill S, Jolly S, Lamy A, Ling E, Magloire P, Pare G, Reddy D, Szalay D, Tittley J, Weitz J, Whitlock R, Darvish-Kazim S, Debeer J, Kavsak P, Kearon C, Mizera R, O'Donnell M, McQueen M, Pinthus J, Ribas S, Simunovic M, Tandon V, Vanhelder T, Winemaker M, Gerstein H, McDonald S, O'Bryne P, Patel A, Paul J, Punthakee Z, Raymer K, Salehian O, Spencer F, Walter S, Worster A, Adili A, Clase C, Cook D, Crowther M, Douketis J, Gangji A, Jackson P, Lim W, Lovrics P, Mazzadi S, Orovan W, Rudkowski J, Soth M, Tiboni M, Acedillo R, Garg A, Hildebrand A, Lam N, Macneil D, Mrkobrada M, Roshanov PS, Srinathan SK, Ramsey C, John PS, Thorlacius L, Siddiqui FS, Grocott HP, McKay A, Lee TW, Amadeo R, Funk D, McDonald H, Zacharias J, Villar JC, Cortes OL, Chaparro MS, Vasquez S, Castaneda A, Ferreira S, Coriat P, Monneret D, Goarin JP, Esteve CI, Royer C, Daas G, Chan MT, Choi GY, Gin T, Lit LC, Xavier D, Sigamani A, Faruqui A, Dhanpal R, Almeida S, Cherian J, Furruqh S, Abraham V, Afzal L, George P, Mala S, Schunemann H, Muti P, Vizza E, Wang CY, Ong GS, Mansor M, Tan AS, Shariffuddin II, Vasanthan V, Hashim NH, Undok AW, Ki U, Lai HY, Ahmad WA, Razack AH, Malaga G, Valderrama-Victoria V, Loza-Herrera JD, De Los Angeles Lazo M, Rotta-Rotta A, Szczeklik W, Sokolowska B, Musial J, Gorka J, Iwaszczuk P, Kozka M, Chwala M, Raczek M, Mrowiecki T, Kaczmarek B, Biccard B, Cassimjee H, Gopalan D, Kisten T, Mugabi A, Naidoo P, Naidoo R, Rodseth R, Skinner D, Torborg A, Paniagua P, Urrutia G, Maestre ML, Santalo M, Gonzalez R, Font A, Martinez C, Pelaez X, De Antonio M, Villamor JM, Garcia JA, Ferre MJ, Popova E, Alonso-Coello P, Garutti I, Cruz P, Fernandez C, Palencia M, Diaz S, Del Castillo T, Varela A, de Miguel A, Munoz M, Pineiro P, Cusati G, Del Barrio M, Membrillo MJ, Orozco D, Reyes F, Sapsford RJ, Barth J, Scott J, Hall A, Howell S, Lobley M, Woods J, Howard S, Fletcher J, Dewhirst N, Williams C, Rushton A, Welters I, Leuwer M, Pearse R, Ackland G, Khan A, Niebrzegowska E, Benton S, Wragg A, Archbold A, Smith A, McAlees E, Ramballi C, Macdonald N, Januszewska M, Stephens R, Reyes A, Paredes LG, Sultan P, Cain D, Whittle J, Del Arroyo AG, Sessler DI, Kurz A, Sun Z, Finnegan PS, Egan C, Honar H, Shahinyan A, Panjasawatwong K, Fu AY, Wang S, Reineks E, Nagele P, Blood J, Kalin M, Gibson D, Wildes T; Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Writing Group, on behalf of The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Investigators; Appendix 1. The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study Investigators Writing Group; Appendix 2. The Vascular events In noncardiac Surgery patIents cOhort evaluatioN Operations Committee; Vascular events In noncardiac Surgery patIents cOhort evaluatioN VISION Study Investigators. Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes. Anesthesiology. 2014 Mar;120(3):564-78. doi: 10.1097/ALN.0000000000000113.
- Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, Srinathan S, Biccard BM, Chow CK, Abraham V, Tiboni M, Pettit S, Szczeklik W, Lurati Buse G, Botto F, Guyatt G, Heels-Ansdell D, Sessler DI, Thorlund K, Garg AX, Mrkobrada M, Thomas S, Rodseth RN, Pearse RM, Thabane L, McQueen MJ, VanHelder T, Bhandari M, Bosch J, Kurz A, Polanczyk C, Malaga G, Nagele P, Le Manach Y, Leuwer M, Yusuf S. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012 Jun 6;307(21):2295-304. doi: 10.1001/jama.2012.5502.
- O'Logbon J, Tarantola L, Williams NR, Mehta S, Ahmed A, Davies EA. Does propranolol have a role in cancer treatment? A systematic review of the epidemiological and clinical trial literature on beta-blockers. J Cancer Res Clin Oncol. 2025 Jul 12;151(7):212. doi: 10.1007/s00432-025-06262-2.
- Hiller JG, Cole SW, Crone EM, Byrne DJ, Shackleford DM, Pang JB, Henderson MA, Nightingale SS, Ho KM, Myles PS, Fox S, Riedel B, Sloan EK. Preoperative beta-Blockade with Propranolol Reduces Biomarkers of Metastasis in Breast Cancer: A Phase II Randomized Trial. Clin Cancer Res. 2020 Apr 15;26(8):1803-1811. doi: 10.1158/1078-0432.CCR-19-2641. Epub 2019 Nov 21.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KC26MISV0115
- KCT0011912 (기타 식별자: Clinical Research Information Service)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
유방암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)완전한피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
SB Istanbul Education and Research Hospital아직 모집하지 않음Thryoid cancer | parathyrıoid 선종
-
Jonsson Comprehensive Cancer CenterNovartis Pharmaceuticals모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Society for Endocrinology초대로 등록
-
Jonsson Comprehensive Cancer Center모병거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
propranolol에 대한 임상 시험
-
Tel-Aviv Sourasky Medical CenterNational Cancer Institute (NCI); The Chaim Sheba Medical Center모병