Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation - Full Text View

Purpose

The main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of Hodgkin's disease. In this study, we would also like to screen for cardiac risk factors that can be modified either through life-style changes or medications, to uncover significant abnormal heart findings in which treatments may be needed, and to see if there is a link between cardiac health and quality of life.

Condition	Intervention
Hodgkin's Disease	Procedure: Echocardiogram Stress Test

MedlinePlus related topics:

Cancer Hodgkin's Disease Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the feasibility of a cardiac screening program in patients who are 5 to 10 years our from initial mediastinal irradiation for Hodgkin's disease. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To prospectively collect data on the prevalence of modifiable cardiac risk factors and the spectrum of cardiac structural abnormalities in this patient populations [ Time Frame: 3 years ] [ Designated as safety issue: No ]
to correlate cardiac structural abnormalities with quality of life and level of fatigue. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	February 2004
Estimated Study Completion Date:	October 2009
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Stress Echocardiogram is made up of three parts: Resting echo study, stress test and repeat echo while the heart is still beating fast. This will be performed by a preventative cardiologist.

Detailed Description:

On the day of the patient's scheduled follow-up visit with their oncologist, additional blood work will be obtained and the patient will fill out questionnaires concerning their general health and assessing quality of life.
A separate cardiology visit with a preventative cardiologist will be performed. At this visit, the patient will undergo a Stress Echocardiogram.
A Stress Echocardiogram is made up of three parts: Resting echo study, stress test and repeat echo while the heart is still beating fast.
A resting echo provides the baseline examination and demonstrates the size and function of various chambers of the heart.
The stress test involves exercise using a treadmill or a stationary bike. In patients who are unable to complete a high level of exercise due to physical limitations, stress to the heart is provided by a pharmaceutical or chemical stimulation to the heart. Exercise is started at a slower, warm-up speed and then increased every 3 minutes. Exercise is abruptly stopped once the patient exceeds 85% of the target rate. EKG recordings are made every minute of exercise and then again after exercise is stopped. Blood pressure is recorded at three minute intervals during exercise and then again at rest.
Immediately after exercise is stopped, the patient will undergo a repeat echocardiogram.
If no cardiac abnormalities are detected, the screening tests will be repeated every 3 years, if the patient is less than 10 years out from their initial treatment. If the patient is more than 10 years from initial treatment, then the tests will be repeated at approximately 18 months from the initial screening and once more at the end of the third year.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients treated at Brigham and Women's Hospital or Dana-Farber Cancer Institute for Hodgkin's disease with mediastinal irradiation
Age > or = to 15 years of age
Five years or longer after initial treatment
Relapse-free interval of > 1 year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165425

Locations


United States, Massachusetts
	Dana-Farber Cancer Institute
	Boston, Massachusetts, United States, 02115
	Brigham and Women's Hospital
	Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators


Principal Investigator:	Peter Mauch, MD	Dana-Farber Cancer Institute

More Information

Responsible Party:	Brigham and Women's Hospital ( Andrea Ng, MD )
Study ID Numbers:	03-295
First Received:	September 9, 2005
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00165425
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Cardiac screening

Cardiac stress test

Echocardiogram

Study placed in the following topic categories:

Lymphatic Diseases

Hodgkin's disease

Immunoproliferative Disorders

Hodgkin lymphoma, adult

Stress

Lymphoproliferative Disorders

Lymphoma

Hodgkin Disease

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165425