This trial is active, not recruiting.

Condition hodgkin's disease
Treatment echo/stress echo
Sponsor Dana-Farber Cancer Institute
Collaborator Brigham and Women's Hospital
Start date February 2004
End date October 2007
Trial size 210 participants
Trial identifier NCT00165425, 03-295


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Participants will meet with study cardiologist undergo cardiac risk factors screening undergo resting and stress echocardiogram
echo/stress echo
Participants will under resting echocardiogram and stress echocardiogram and the results will be interpreted by a cardiologist

Primary Outcomes

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

Secondary Outcomes

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
to correlate cardiac structural abnormalities with quality of life and level of fatigue.
time frame: 3 years

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation
Principal investigator Peter Mauch, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.