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Completed

NCT Number: NCT03930680

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

The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexrazoxane

Drug

One dose of dexrazoxane

Other names: Zinecard

Primary outcomes

  1. Participants With 95% Reduction in Topoisomerase 2 b From Baseline

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: PHOENIX1

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Apr 29, 2019
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.