NCT03930680

Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane

Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Degradation of Top2b and Top2a in Human by Dexrazoxane
• Time Course and Degradation of Top2b in Human by Dexrazoxane
• Effects of Dexrazoxane on Healthy Human

Interventions

Type	Name	Description
DRUG	Dexrazoxane	One dose of dexrazoxane

Timeline

• Start date: 2021-09-14
• Primary completion: 2024-06-11
• Completion: 2025-06-11
• First posted: 2019-04-29
• Last updated: 2025-07-08
• Results posted: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study