Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment

Official Title

Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy

Summary:

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

Trial Description

Primary Outcome:

  • Left ventricular thickness-to-dimension ratio assessed using standard 2-dimensional.
  • Left ventricular thickness-to-dimension ratio assessed using M-mode.
  • Left ventricular thickness-to-dimension ratio assessed using Doppler echocardiogram.
Secondary Outcome:
  • Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides)
  • Primary disease relapse
  • Quality of life based on self-report instruments
  • Second cancer rates
PRIMARY OBJECTIVES:
I. To determine whether patients randomized to the experimental dexrazoxane hydrochloride (DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with patients on the standard arm. II. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline (anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at cancer diagnosis, current age, sex). SECONDARY OBJECTIVES:
I. To determine whether patients on the DRZ arms experienced differential rates of overall-survival and event-free survival compared with the standard therapy arms. II. To determine whether projected quality-adjusted life years (QALY) differed by randomization status, accounting for premature cardiac disease, primary disease relapse, and second cancers. OUTLINE:

Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram, collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of life, family history, physical activity, and smoking questionnaires.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society