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

Phase 1

Completed

• 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: Drug: 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

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Study Start: 2021-09-14
• Primary Completion: 2024-06-11
• Results First Submitted: 2025-04-21
• Status Verified: 2025-06
• Study Completion: 2025-06-11
• Results First Submitted QC: 2025-06-11
• Results First Posted: 2025-06-12
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• 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
Participants With 95% Reduction in Topoisomerase 2 b From Baseline	8 hours after dexrazoxane administration	Number of participants with 95% reduction in topoisomerase 2 b from baseline is reported in the Outcome Measure Data Table

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States