Preventing heart failure caused by Doxorubicin with Dexrazoxane
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer
This study is testing if giving Dexrazoxane early can help protect the hearts of healthy volunteers from damage caused by the cancer drug Doxorubicin.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Arkansas Academic / other |
| Drugs / interventions | Doxorubicin |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT03930680 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether early administration of Dexrazoxane can prevent cardiotoxicity induced by Doxorubicin in healthy volunteers. Participants will receive a single dose of Dexrazoxane, and blood samples will be collected to analyze the degradation of Topoisomerase 2b and Topoisomerase 2a over time. The study focuses on determining the effective dose of Dexrazoxane and its impact on these biomarkers. The findings could provide insights into protecting heart health during cancer treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women aged 18-65 who are not pregnant or breastfeeding.
Not a fit: Patients with a history of cardiac or renal disease, or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of heart failure in patients receiving Doxorubicin.
How similar studies have performed: While this approach is novel in its specific application, similar studies have explored the cardioprotective effects of Dexrazoxane in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Hui-Ming Chang, MD,MPH — University of Arkansas
- Study coordinator: Hui-Ming Chang, MD,MPH
- Email: hchang@uams.edu
- Phone: 501-686-7575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.