Radiation Therapy and Cardiac Enzymes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00777751
First received: October 21, 2008
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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
Tumor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Radiation Therapy and Cardiac Biomarkers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777751

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00777751     History of Changes
Other Study ID Numbers: 2007-0489
Study First Received: October 21, 2008
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014