Strain Echocardiography to Predict Cardiotoxicity in Patients Receiving Chemotherapy Containing Doxorubicin

Completed

Conditions studied: Breast Neoplasms, Lymphoma, Sarcoma

In brief

The purpose of this study is to investigate the heart functioning of patients being treated with with doxorubicin chemotherapy who have sarcoma, lymphoma or breast cancer in order to better predict risk of developing symptomatic heart failure.

Key facts

Study ID

NCT02423356

Run by

Daniel Rushing

People needed

12

Starts

2015-04-23

Expected to finish

2018-02-01

Last updated by the study team

2018-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be at least 18 years old at the time of informed consent
• Patients must be able to speak and read English.
• Patients must be able to provide written informed consent and HIPAA authorization
• Patients must have a current diagnosis of sarcoma, lymphoma, or HER2(-) breast cancer
• Patients must be deemed appropriate for doxorubicin-based chemotherapy regardless of individual diagnosis or stage of disease.
• Patients must have planned treatment with doxorubicin:
• Patients with sarcoma must have an initial planned regimen including 75 mg/m2 doxorubicin for at least 4 cycles. NOTE: Patients can be on additional chemotherapeutic agents.
• Patients with lymphoma must have an initial planned regimen including 50 mg/m2of doxorubicin for at least 6 cycles. NOTE: Patients can be on additional chemotherapeutic agents.
• Patients with breast cancer must have an initial planned regimen including 60 mg/m2 of doxorubicin for at least 4 cycles. Breast cancer patient enrollment will stop once 60 breast cancer patients have been enrolled.
• NOTE: Patients can be on additional chemotherapeutic agents.
• Patients must have their echocardiograms performed such that strain may be calculated using either GE or Tomtec software.

You may not qualify if…

• Clinical history of heart failure or ejection fraction (EF) on initial exam is <53%.
• Initial echocardiograms are not interpretable.
• Wall motion abnormalities are present on initial echocardiograms.
• Strain on initial echocardiograms cannot be calculated.

Where it is running

• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.