Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane
- Registration Number
- NCT03930680
- Lead Sponsor
- University of Arkansas
- Brief Summary
The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.
- Detailed Description
This is a study on volunteers to determine effective dose of dexrazoxane in degrading Topoisomerase 2 b in human blood samples. Each participant will receive one dose of dexrazoxane. Blood samples will be collected to determine the time course and degradation of Topoisomerase 2b and Topoisomerase 2a
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 25
Inclusion Criteria
- Women,
- Age 18-65,
- Not pregnant, Not currently breast feeding
- No current illness,
Exclusion Criteria
- Pregnancy, currently breast feeding
- Current illness,
- History of cardiac, or renal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexrazoxane 100mg/m2 Dexrazoxane one dose of 100mg/m2 dexrazoxane Dexrazoxane 200mg/m2 Dexrazoxane one dose of 200mg/m2 dexrazoxane Dexrazoxane 300mg/m2 Dexrazoxane one dose of 300mg/m2 dexrazoxane Dexrazoxane 400mg/m2 Dexrazoxane one dose of 400mg/m2 dexrazoxane Dexrazoxane 500mg/m2 Dexrazoxane one dose of 500 mg/m2
- Primary Outcome Measures
Name Time Method Degradation of Topoisomerase 2 b 48 hours after administration Topoisomerase 2 b degradation to less than 15 percent of baseline level in human blood of 5 volunteers.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States