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Radiation Therapy and Cardiac Biomarkers

18 Years
Open (Enrolling)

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Trial Information

Radiation Therapy and Cardiac Biomarkers

Cardiac Biomarkers:

Cardiac biomarkers are proteins made by the heart. When cardiac biomarkers are above normal
levels, there may be damage to the heart. 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. How cardiac biomarkers can play
a role in predicting future heart problems during radiation therapy will also be studied.

Study Tests:

If you agree to take part in this study, blood (about 1 teaspoon) will be drawn to measure
certain cardiac biomarkers up to 2 days before radiation therapy, following the first
treatment of radiation, within 2 days of finishing radiation therapy, and about 1 to 2
months after completion of radiation therapy. Once the blood testing is completed, any
leftover blood samples will be destroyed.

You will also have electrocardiograms (ECGs -- tests that measure the electrical activity
of the heart) at the same time points as the blood draws.

Length of Study:

You will be off study after the last blood draw and ECG.

This is an investigational study. Up to 30 patients will be enrolled in this study. All
will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. A total of thirty patients will be prospectively enrolled in this study. Patients
with tumors in the chest including histologically proven primary lung cancer,
esophageal cancer, thymoma or mesothelioma to be treated with RT with or without
concurrent chemotherapy to a final dose of >/=45 Gy will be included in this study.

2. Patients with tumors in close proximity to the heart where the treating radiation
oncologist anticipates the mean cardiac dose will exceed 20Gy.

3. All patients must sign a study-specific informed consent form. If the patient's
mental status precludes his/her giving informed consent, written informed consent may
be given by the patient's legal representative.

4. Age >/= 18

5. Women of childbearing potential (A woman of child-bearing potential is a sexually
mature woman who has not undergone a hysterectomy or who has not been naturally
postmenopausal for at least 24 consecutive months [i.e., who has had menses at any
time in the preceding 24 consecutive months]. For women of childbearing potential, a
blood pregnancy test must be performed within 72 hours prior to the start of protocol

Exclusion Criteria:

1. Patients who receive 5-fluorouracil or adriamycin as part of their chemotherapy

2. Patients with recent myocardial infarction in the past month, decompensated heart
failure or myocarditis/pericarditis in the past month

3. Patients with renal failure indicated by a serum creatinine level of >/= 2.0.

4. Patients in the intensive care unite (ICU).

5. Patients with systemic sepsis.

6. Patients with acute pulmonary embolism in the past month.

7. Women who are pregnant or nursing are not eligible as treatment involves
unforeseeable risks to the fetus or child.

8. Inability to obtain histologic proof of malignancy.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Elevation in cardiac biomarkers by measuring cardiac troponins (troponin T and troponin I), BNP, and CK-MB.

Outcome Time Frame:

4 Time Points: within 1 week prior to radiation therapy (RT), within 1-3 days of RT completion, and at 1 and 3 months after completion of RT.

Safety Issue:


Principal Investigator

David Grosshans, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Tumor
  • Chest Tumor
  • Heart
  • Lung Cancer
  • Esophageal Cancer
  • Thymoma
  • Radiation dose to the heart
  • Cardiac Enzymes
  • Cardiac Biomarkers
  • Radiation Therapy
  • RT
  • Electrocardiograms
  • ECG



UT MD Anderson Cancer Center Houston, Texas  77030