Radiation Therapy and Cardiac Enzymes



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2018
Start Date:October 6, 2008
End Date:November 21, 2016

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Radiation Therapy and Cardiac Biomarkers

The goal of this clinical research study is to learn if the radiation that you are receiving
will result in an increase in certain proteins produced by the heart called 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
treatment.

Exclusion Criteria:

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

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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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