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


N/A
20 Years
N/A
Open (Enrolling)
Both
Hodgkin's Disease

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome 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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Peter Mauch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

03-295

NCT ID:

NCT00165425

Start Date:

February 2004

Completion Date:

April 2013

Related Keywords:

  • Hodgkin's Disease
  • Cardiac screening
  • Cardiac stress test
  • Echocardiogram
  • Hodgkin Disease

Name

Location

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