Clinical trial NCT00165425: Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation
Official title: Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hodgkin's Disease
Keywords: Cardiac screening
Cardiac stress test
Echocardiogram
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-09-14
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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

Exclusion criteria:

* Patients treated for Hodgkin's disease outside of Brigham and Women's Hospital or Dana-Farber Cancer Institute
* Current age \< 15 years of age
* Less than 5 years out from initial treatment
* Relapses within 1 year

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: To prospectively collect data on the prevalence of modifiable cardiac risk factors and the spectrum of cardiac structural abnormalities in this patient populations
timeFrame: 3 years
measure: to correlate cardiac structural abnormalities with quality of life
timeFrame: 3 years
measure: to correlate cardiac structural abnormalities with level of fatigue.
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Andrea K. Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: