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Radiation Therapy and Cardiac Enzymes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777751
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease
Tumor

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Radiation Therapy and Cardiac Biomarkers
Actual Study Start Date : October 6, 2008
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : November 21, 2016

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Elevation in cardiac biomarkers by measuring cardiac troponins (troponin T and troponin I), BNP, and CK-MB. [ 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. ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tumors in the chest in close proximity to the heart, including histologically proven primary lung cancer, esophageal cancer, or thymoma, to be treated with single modality RT.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777751


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: David Grosshans, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00777751    
Other Study ID Numbers: 2007-0489
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Chest Tumor
Heart
Lung Cancer
Esophageal Cancer
Thymoma
Radiation dose to the heart
 Cardiac Enzymes
Cardiac Biomarkers
Radiation Therapy
RT
Electrocardiograms
ECG