Esophageal Cancer Clinical Trial
Official title:
Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation
The goal of this clinical research study is to learn if the radiation that you will receive
for esophageal cancer may cause the heart to create more proteins called cardiac biomarkers.
When cardiac biomarkers are above normal levels, there may be heart damage. The relationship
between cardiac biomarkers and radiation therapy has not been well studied. Learning more
about this relationship may lead to better ways to check the heart during radiation therapy
and predict heart problems.
If you are found to be eligible and you agree to take part in this study, you will have
baseline tests. The following tests and procedures will be performed within 1-2 weeks from
the start of radiation:
- You will be asked about any other health problems you may have.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.
- You will have an electrocardiogram (ECG) to check your heart function.
- If the study doctor thinks it is needed, you will have an exam by a cardiologist (a
doctor who diagnoses and treats heart problems) who will check the results of your ECG.
Study Visits:
Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers at the following time
points:
- Within 12-24 hours of the start of radiation
- One (1) time during the third week of radiation
- Within 48 hours after completion of radiation
Follow-Up:
About 1 to 2 months after you complete radiation therapy, depending on when you and your
doctor decide, you will return to the clinic. The following tests and procedures will be
performed:
- Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.
- You will have an ECG.
Length of Study Participation:
You will be off study after your follow-up visit.
You will no longer be able to take part in the study if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Using cardiac biomarkers to check the heart during
radiation therapy to predict future heart problems is considered investigational.
Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.
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