Cardioprotective Empagliflozin for Cancer Patients Receiving Doxorubicin

Sponsor
Ain Shams University
Study ID
NCT06103279
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 30, 2023
Status verified
Oct 2023
Primary completion
Jul 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Empa Arm
    (Intervention group = 20 patients) \>\> will receive the standard chemotherapy protocol (DOX-based chemotherapy) plus Empagliflozin. Empagliflozin dose and duration: According to the Evidence-based doses of disease-modifying drugs in key randomized trials in patients with heart failure with reduced ejection fraction with or without diabetes, The recommended dose of empagliflozin is 10 mg once daily. 1 tablet once daily of continuously starting from 1 week before starting DOX till the end of last Dox-based chemotherapy dose according to the given chemotherapy protocol.
  • No Intervention: Control Arm
    (Control group = 20 patients) \>\> will receive the standard chemotherapy protocol (DOX-based chemotherapy) only.

Primary Outcome Measure

''Cardiac troponin T'' [ Time Frame: Baseline and one time at the end of chemotherapy (3 to 5 days after the last dose of doxorubicin). ]

Central Contacts

Related Studies