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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hodgkin's Disease
• Intervention / Treatment: Procedure: Echo/Stress Echo

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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac screening; Interventions: Participants will; meet with study cardiologist; undergo cardiac risk factors screening; undergo resting and stress echocardiogram (echo and stress echo)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital
• Investigators: Principal Investigator: Peter Mauch, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): October 1, 2007
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimated): September 14, 2005

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Echocardiogram; Cardiac screening; Cardiac stress test
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: 03-295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO