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Cardioprotective Empagliflozin for Cancer Patients Receiving Doxorubicin

NCT06103279 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-26

No results posted yet for this study

Summary

Doxorubicin induced cardiomyopathy is the most common and serious side effect associated with doxorubicin treatment in cancer patients receiving doxorubicin. Studies have been shown that Empagliflozin can reduce cardiovascular mortality and hospitalization for heart failure in patients with heart failure with or without diabetes and current clinical trials indicate that SGLT2 inhibitors protect against heart failure outcomes and can reduce cardiac remodeling even in patients without diabetes. Empagliflozin had beneficial effects on the outcome of the cardiomyopathy and also has anti-tumor activity in animal studies, but clinical studies are still lacking. We are going to investigate the cardioprotective effect of Empagliflozin against doxorubicin induced cardiomyopathy.

Objective:

* Evaluate the prophylactic effect of using Empagliflozin "a selective inhibitor of the sodium glucose co-transporter 2 (SGLT2)" against doxorubicin induced cardiotoxicity in patients receiving doxorubicin-based chemotherapy.
* Monitor the safety of adding empagliflozin to doxorubicin-based chemotherapy.

Conditions

Interventions

DRUG

Empagliflozin 10 MG

1 tablet once daily of (EMPAGLIMAX® 10 mg) continuously starting from 1 week before starting doxorubicin till the end of last Dox-based chemotherapy dose according to the given chemotherapy protocol

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-07-31
Completion
2024-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103279 on ClinicalTrials.gov