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| ID | Type | Description | Link |
|---|---|---|---|
| KCT0011912 | Other Identifier | Clinical Research Information Service |
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| Name | Class |
|---|---|
| Seoul St. Mary's Hospital | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol Group | Experimental | 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. |
|
| Non-Propranolol Group (Usual Care) | Active Comparator | Participants will receive standard clinical care for hypertension or angina without the use of Propranolol or other beta-blockers before surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propranolol | Drug | Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| From the day of surgery (Day 0) up to 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During surgery and in the recovery room (up to 2hours post-surgery)(Day 0) |
| Perioperative Hemodynamic Stability: Heart rate Fluctuation |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index | 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 |
Inclusion Criteria:
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:
â‘ ANC <1,500/mm3
Platelets <100,000/mm3
Hb <9 g/dL
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinah Lee, MD | Contact | 82-10-8573-9324 | jinahsmile@naver.com | |
| Chang Ik Yoon, MD, Ph.D. | Contact | 82-10-8774-0103 | fayn@daum.net |
| Name | Affiliation | Role |
|---|---|---|
| Chang Ik Yoon, MD, Ph.D. | Seoul St. Mary's Hospital, The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | Seoul | 06591 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40652143 | Result | 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. | |
| 31754048 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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This is a prospective, randomized, open-label, two-arm, single-center pragmatic clinical trial. Eligible patients are randomized in a 1:1 ratio into either the Propranolol group or the Non-propranolol group, stratified by cancer stage (Stage 1 vs. Stage 2/3). The study evaluates the real-world clinical impact of preoperative propranolol administration on postoperative myocardial injury.
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| Usual Care | Other | Standard medical management (e.g., CCB, ACEi, ARB, or diuretics) at the physician's discretion, excluding beta-blockers. |
|
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 | Incidence of major cardiovascular and respiratory complications, including MI, CVA, MINS, and pulmonary complications. | Within 30 days after surgery |
| length of hospital stay | 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) | 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 |
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 | 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) | 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) | 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) | 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) | 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) | 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 | Descriptive analysis of recurrence status, invasive disease-free survival (iDFS), and overall survival (OS) | Up to 5 years after surgery |
| Molecular and Immunological 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) |
| 22706835 | Result | 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. |
| 24534856 | Result | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |