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Effects of Melatonin and Ranolazine on Trastuzumab-Induced Cardiac Dysfunction in HER2-Positive Breast Cancer Patients

Effects of Melatonin and Ranolazine on Trastuzumab-Induced Cardiac Dysfunction in HER2-Positive Breast Cancer Patients

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231110007
Enrollment
60
Registered
2023-11-10
Start date
2020-09-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive breast cancer Cardiotoxicity Breast cancer Cardiotoxicity

Interventions

Aim 1: To determine the temporal changes of biomarkers, cardiac function, mitochondrial function, oxidative stress and cell viability in isolated PBMCs in breast cancer patients receiving sequential d
Control,Melatonin,Ranolazine

Sponsors

The National Science and Technology Development Agency Thailand
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Newly diagnosed breast cancer, required breast surgery and chemotherapy - Over-expressed HER2 in breast cancer

Exclusion criteria

Exclusion criteria: - HER2-negative breast cancer - Metastatic breast cancer at diagnosis, except lymph node and bone metastasis - History of other cancer(s) - Prior chemotherapy - LVEF below 53% at baseline or below 50% before trastuzumab treatment - End-stage disease (i.e., renal, liver) or life expectancy less than 1 year - Pregnancy - Allergy to medications used in the study - Corrected QT interval more than 500 ms - Informed or treatment refusal

Design outcomes

Primary

MeasureTime frame
Global longitudinal strain 12 months Echocardiography

Secondary

MeasureTime frame
Mitochondrial respiration in PBMCs 12 months Seahorse extracellular flux analyzer,Oxidative stress in PBMCs 12 months MitoSOX/MitoTracker staining ,Cell viability in PBMCs 12 months Propidium iodide flow cytometry

Countries

Thailand

Contacts

Public ContactSiriluck Gunaparn

Faculty of Medicine, Chiang Mai University

sgunaparn@gmail.com053936643

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026