Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT00165425

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Hodgkin's Disease Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echo/Stress Echo

Procedure

Participants will under resting echocardiogram and stress echocardiogram (echo and stress echo) and the results will be interpreted by a cardiologist

Primary outcomes

  1. 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

    Compliance of screening and follow up visits are tracked

Secondary outcomes

  1. 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

    Data on modifiable cardiac risk factors, and outcome of screening studies, are collected prospectively

  2. to correlate cardiac structural abnormalities with quality of life

    Time frame: 3 years

    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. to correlate cardiac structural abnormalities with level of fatigue.

    Time frame: 3 years

    Responses to the fatigue subscale of FACT-Fatigue (FACT-F), collected at the time of initial visit, will be correlated with cardiac screening results

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2028
First posted
Sep 14, 2005
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.