Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery

NCT07583134 | Not Yet Recruiting Phase 4

• 2 other identifiers: KC26MISV0115KCT0011912
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Myocardial Injury After Noncardiac Surgery (MINS)

Keywords

Propranolol; Breast Cancer Surgery; Beta-blockers; Tumor Microenvironment; Pragmatic Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (5)

• Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation

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

• Perioperative Hemodynamic Stability: Heart rate Fluctuation

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

• Postoperative Cardiovascular and Respiratory Complications Rate

  Within 30 days after surgery

• length of hospital stay

  Within 30 days after surgery

• Change in Patient-Reported Anxiety (HADS-A)

  Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery

Other Outcomes (10)

• Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index

  At the time of surgery (Day 0)

• Tumor Microenvironment and Biological Markers: Histological Grade

  At the time of surgery (Day 0)

• Tumor Microenvironment and Biological Markers: Presence of Lymphovascular Invasion

  At the time of surgery (Day 0)

Study Arms (2)

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.

Drug: propranolol

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

Other: Usual Care

Interventions

propranolol DRUG

Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.

Propranolol Group

Usual Care OTHER

Standard medical management (e.g., CCB, ACEi, ARB, or diuretics) at the physician's discretion, excluding beta-blockers.

Non-Propranolol Group (Usual Care)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang-Ik Yoon: lead
• Seoul St. Mary's Hospital: collaborator

Study Sites (1)

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, Seoul, 06591, South Korea

Location

Related Publications (4)

• 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.

  PMID: 40652143 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.

  PMID: 31754048 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.

  PMID: 22706835 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.

  PMID: 24534856 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Chang Ik Yoon, MD, Ph.D.

  Seoul St. Mary's Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Seoul St. Mary's Hospital

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): May 26, 2026
• Primary Completion (Estimated): May 23, 2028
• Study Completion (Estimated): May 24, 2033
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)