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

Hodgkin's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00165425
• Other study ID #: 03-295
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2004
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: December 2025
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease

Intervention

Procedure:
• Echo/Stress Echo
Participants will under resting echocardiogram and stress echocardiogram (echo and stress echo) and the results will be interpreted by a cardiologist

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Compliance of screening and follow up visits are tracked	3 years
Secondary	To prospectively collect data on the prevalence of modifiable cardiac risk factors and the spectrum of cardiac structural abnormalities in this patient populations	Data on modifiable cardiac risk factors, and outcome of screening studies, are collected prospectively	3 years
Secondary	to correlate cardiac structural abnormalities with quality of life	Responses to the generic quality-of-life questionnaire Short-Form 36 (SF-36) collected at the time of initial visit, will be correlated with cardiac screening results	3 years
Secondary	to correlate cardiac structural abnormalities with level of fatigue.	Responses to the fatigue subscale of FACT-Fatigue (FACT-F), collected at the time of initial visit, will be correlated with cardiac screening results	3 years