Prevention of Heart Failure Induced by Doxorubicin with Early Administration of Dexrazoxane
Purpose
The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.
Condition
- Healthy
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Each subject will receive one dose of dexrazoxane.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dexrazoxane 100mg/m2 |
one dose of 100mg/m2 dexrazoxane |
|
|
Experimental Dexrazoxane 200mg/m2 |
one dose of 200mg/m2 dexrazoxane |
|
|
Experimental Dexrazoxane 300mg/m2 |
one dose of 300mg/m2 dexrazoxane |
|
|
Experimental Dexrazoxane 400mg/m2 |
one dose of 400mg/m2 dexrazoxane |
|
|
Experimental Dexrazoxane 500mg/m2 |
one dose of 500 mg/m2 |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
More Details
- NCT ID
- NCT03930680
- Status
- Recruiting
- Sponsor
- University of Arkansas
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