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Clinical Study to Evaluate the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a randomized controlled clinical trial that aims to evaluate the safety and efficacy of Dapagliflozin as a cardioprotective in doxorubicin-induced cardiotoxicity in breast cancer patients.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age ≥18 years old.

• Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).

• Patients intended to receive at least 4 cycles of doxorubicin or more.

• Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.

• Echocardiographic LVEF ≥55%.

• Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).

• Patients with adequate liver function and adequate renal function.

• Signed informed consent to participate in the study.

Locations
Other Locations
Egypt
Medical Research Institute
RECRUITING
Alexandria
Contact Information
Primary
Sandy Rezkallah, Bachelor
sandyehab58@gmail.com
01221065882
Backup
Osama M Ibrahim, Professor
osama.mohamed.ibrahim@pharm.tanta.edu.eg
Time Frame
Start Date: 2024-10-31
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 46
Treatments
No_intervention: Control Group
23 breast cancer patients which will receive four cycles of AC regimen (Doxorubicin and Cyclophosamide; each cycle is given every 21 days) only.
Active_comparator: Dapagliflozin group
23 breast cancer patients which will receive four cycles of AC regimen (Doxorubicin and Cyclophosamide; each cycle is given every 21 days) plus Dapagliflozin 10 mg once daily.
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov