Radiation Therapy and Cardiac Enzymes

NCT00777751 | Completed

• 1 other identifier: 2007-0489
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Patients with tumors in close proximity to the heart where the treating radiation oncologist anticipates the mean cardiac dose will exceed 20Gy.
• 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.
• Age \>/= 18
• 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.

You may not qualify if:

• Patients who receive 5-fluorouracil or adriamycin as part of their chemotherapy regimen.
• Patients with recent myocardial infarction in the past month, decompensated heart failure or myocarditis/pericarditis in the past month
• Patients with renal failure indicated by a serum creatinine level of \>/= 2.0.
• Patients in the intensive care unite (ICU).
• Patients with systemic sepsis.
• Patients with acute pulmonary embolism in the past month.
• Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child.
• Inability to obtain histologic proof of malignancy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms; Esophageal Neoplasms; Thymoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Thymus Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• David Grosshans, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: October 6, 2008
• Primary Completion: November 21, 2016
• Study Completion: November 21, 2016
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

US (1)