Comparative Study Between (SGLT-2i) and (DPP-4i) in the Prevention of DIC

Summary

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.

Conditions

• Breast Cancer

Interventions

DRUG

Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy

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.

DRUG

Sitagliptin (DPP4 inhibitor)

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.

OTHER

Standard Care (in control arm)

Usual care without prophylactic cardioprotective agent (guideline directed initiation permitted if clinically indicated post randomization; recorded and adjusted for).

Sponsors & Collaborators

• Tanta University

  lead OTHER

Principal Investigators

• Mohamed Abdelhamid Almeldein, Professor · Tanta University

• Mohamed Elhussieny Shams, Professor · Mansoura University

• Haidy Mahmoud Sami, Lecturer · Delta University

• Osama Hamid Shoaeb, Associate Professor · Tanta University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2027-11-01

Completion

2027-12-01