Clinical trial NCT03930680: Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane
Official title: Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
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
Keywords: Dexrazoxane
Topoisomerase 2b
Human
Doxorubicin cardio-toxicity
Cardio-oncology
Onco-cardiology
Prevention of cardio-toxicity by doxorubicin
Early administration of dexrazoxane
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-04-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will receive one dose of dexrazoxane.
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Participants With 95% Reduction in Topoisomerase 2 b From Baseline
timeFrame: 8 hours after dexrazoxane administration
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Hui-Ming Chang, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
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