Effects of metformin and donepezil on the prevention of doxorubicin-induced cardiotoxicity in breast cancer patient, a randomized controlled trial
Phase 4
- Conditions
- Breast cancerDoxorubicinCardiotoxicityMitochondria
- Registration Number
- TCTR20200116007
- Lead Sponsor
- ational Science and Technology Development Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- Female
- Target Recruitment
- 396
Inclusion Criteria
1)Female patient age > 18 years
2)Diagnosis with breast cancer and planned to receive doxorubicin
3)Given informed consent
Exclusion Criteria
1Metastatic breast cancer at diagnosis (except lymph node and bone metastasis)
2Other malignancies
3Prior history of chemotherapy or chest wall radiation
4Prior cardiovascular disease with LVEF < 53% or severe valvular heart disease
5CrCl < 30 ml/min as measured by Cockcroft-Gault Equation
6Patients with baseline EKG show corrected QT interval > 500 msec
7Patients currently receiving metformin or donepezil
8Allergy or contraindication to metformin or donepezil
9Life expectancy < 1 year
10Pregnancy and lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Troponin-I About 2 weeks after completion of doxorubicin therapy Troponin-I level
- Secondary Outcome Measures
Name Time Method Cardiac function and biomarker 2 weeks post doxorubicin, month 3, month 6, month 9, month 12 Echocardiogram for LVEF and GLS, NT-proBNP level, Holter monitoring for HRV result,Markers of mitochondria dynamics, mitochondria function and apoptosis Post chemo C2, C4, C6 - Mitochondrial respiration (Seahorse), Mitochondrial ROS production, Annexin V ,Plasma antioxidant ,Genes associated with doxorubicin-induced cardiotoxicity at baseline PCR for gene analysis of single nucleotide polymorphism