Impact of saffron tablets on Doxorubicin-induced cardiotoxicity

Phase 3

Conditions: Cardiomyopathy.
Cardiomyopathy due to drug and external agent
I42.7

Registration Number: IRCT20120703010178N26

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 188

Inclusion Criteria

Female patients aged 18 to 70 years
Patients with histologically or cytologically proven primary breast cancer
Receiving chemotherapy with doxorubicin, without prior bilateral/unilateral thoracic radiotherapy
Karnofsky score more than 60
Life expectancy more than 6 months

Exclusion Criteria

Patients diagnosed with cardiomyopathy
Patients receiving vitamin K antagonists or DOACs
Patients with chronic kidney disease with eGFR < 30 ml/min/1.73 m2
Patients with serum potassium above 5.5 mmol/L
Patients with severe liver failure (Child-Pough C)
Patients who have previously received anthracycline
Patients who are currently pregnant or breastfeeding
Patients participating in other clinical trials

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of heart failure in study subjects. Timepoint: At the beginning of the study and the end of chemotherapy or three months after the start of chemotherapy (whichever is earlier). Method of measurement: Based on the findings of echocardiography, including ejection fraction and Global Longitudinal Strain (GLS) of the heart, cardiac biomarkers, and ECG according to the definition of the European Heart Association in 2022.

Secondary Outcome Measures

Name	Time	Method
Prooxidant-Antioxidant Balance (PAB). Timepoint: At the beginning of the study and the end of chemotherapy or three months after the start of chemotherapy (whichever is earlier). Method of measurement: Laboratory kit.;Drug adherence. Timepoint: Monthly. Method of measurement: Pill count.