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

12. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Chang Ik Yoon, MD, Ph.D.
  • Telefonnummer: 82-10-8774-0103
  • E-mail: fayn@daum.net

Studiesteder

  • Sydkorea
    • Seoul
      • Seoul, Seoul, Sydkorea, 06591
        • Seoul St. Mary's Hospital, The Catholic University of Korea
        • Kontakt:
        • Kontakt:
          • Chang Ik Yoon, MD, Ph.D.
          • Telefonnummer: 82-10-8774-0103
          • E-mail: fayn@daum.net

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: propranolol
Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
Aktiv komparator: 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
Andet: Usual Care
Standard medical management (e.g., CCB, ACEi, ARB, or diuretics) at the physician's discretion, excluding beta-blockers.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chang-Ik Yoon

Samarbejdspartnere

Seoul St. Mary's Hospital

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

26. maj 2026

Primær færdiggørelse (Anslået)

23. maj 2028

Studieafslutning (Anslået)

24. maj 2033

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KC26MISV0115
  • KCT0011912 (Anden identifikator: Clinical Research Information Service)

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