Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy
DrugDapagliflozin 10 mg orally once daily (dose may increase to 25 mg if tolerated after Cycle 1) starting ≥5 days before first DOX dose and continued for 3 months.
NCT Number: NCT07436663
Background:
Breast cancer is the most frequently diagnosed malignancy among women worldwide and a major cause of morbidity and mortality. Anthracycline-based chemotherapy, particularly doxorubicin, remains a cornerstone of treatment; however, its clinical utility is limited by dose-dependent cardiotoxicity that can lead to irreversible cardiac dysfunction and heart failure. The search for effective cardioprotective interventions is therefore a key priority in cardio-oncology.
Aim:
This study aims to compare the efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors in preventing doxorubicin-induced cardiotoxicity in Egyptian women with breast cancer.
Methods:
A prospective, randomized, controlled clinical trial will be conducted at Oncology Hospital of Tanta University. Eligible adult female patients with histologically confirmed breast cancer scheduled to receive anthracycline-containing chemotherapy will be randomized into three groups: (1) control (standard care), (2) SGLT2 inhibitor group (dapagliflozin 10-25 mg daily), and (3) DPP-4 inhibitor group (sitagliptin 50-100 mg daily). Treatment will start five days before the first chemotherapy cycle and continue for six months, with follow-up for an additional six months. Cardiac function will be assessed by echocardiography (LVEF and GLS) and biomarkers (Cardiac Troponin T, and NT-proBNP). The primary endpoint is the incidence of cardiotoxicity defined by a ≥10% decline in LVEF to <50% or a >15% relative decline in GLS accompanied by biomarker elevation.
Expected Outcomes:
It is anticipated that both SGLT2 and DPP-4 inhibitors will reduce the incidence and severity of doxorubicin-induced cardiotoxicity, with SGLT2 inhibitors expected to demonstrate superior cardioprotective efficacy. Findings from this study may support the integration of cardioprotective antidiabetic agents into oncology care pathways to improve the cardiac outcomes and overall survival of breast cancer patients.
Trial opening soon.
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Interventional
Phase 4
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dapagliflozin 10 mg orally once daily (dose may increase to 25 mg if tolerated after Cycle 1) starting ≥5 days before first DOX dose and continued for 3 months.
Sitagliptin 100 mg orally once daily (50 mg if eGFR 30-45 mL/min/1.73m²) starting ≥5 days before first DOX dose and continued for 3 months.
Usual care without prophylactic cardioprotective agent (guideline directed initiation permitted if clinically indicated post randomization; recorded and adjusted for).
Time frame: Within 3 months from initiation of therapy.
Cardiotoxicity will be defined as the occurrence of any of the following during the study period:
A decline in left ventricular ejection fraction (LVEF) ≥ 10% from baseline resulting in an LVEF < 50%, as measured by echocardiography, or
A relative reduction in global longitudinal strain (GLS) > 15% from baseline, as assessed by speckle-tracking echocardiography.
Unit of Measure: Percentage of participants experiencing cardiotoxicity (%)
Time frame: 3 months
Description:
Absolute change in left ventricular ejection fraction from baseline to 3 months, measured by transthoracic echocardiography.
Unit of Measure: Percentage points (%)
Time frame: 6 months
Description:
Relative percentage change in global longitudinal strain from baseline to 3 months, assessed using speckle-tracking echocardiography.
Unit of Measure: Percentage (%)
Time frame: 6 months
Time frame: 3 months
Change in Cardiac Biomarkers (if applicable)
Description:
Change in serum cardiac biomarker levels (e.g., troponin) from baseline to 3 months.
Troponin: ng/L
Time frame: 3 months
Description:
Change in serum cardiac biomarker levels (e.g., NT-proBNP) from baseline to 3 months.
NT-proBNP: pg/mL
Time frame: 6 months
Contact information is provided by the study sponsor or research team.
Mai Aboelyazed Elgebaly, Associate Lecturer
CONTACT
+0201061412257 ext. 020
Mai Aboelyazed Elgebaly, Associate Lecturer
CONTACT
+201115064114 ext. 020
Tanta University
Other
A Comparative Clinical Study Evaluating the Efficacy of (SGLT2)Inhibitors Versus (DPP-4) Inhibitors in the Prevention of Doxorubicin-Induced Cardiotoxicity Among Egyptian Women With Breast Cancer
Acronym: SGLT2i/DPPi
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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