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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00165425
First Posted: September 14, 2005
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Andrea K. Ng, MD, Dana-Farber Cancer Institute
  Purpose
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.

Condition Intervention
Hodgkin's Disease Procedure: Echo/Stress Echo

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation

Resource links provided by NLM:


Further study details as provided by Andrea K. Ng, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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

  • 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


Enrollment: 210
Study Start Date: February 2004
Estimated Study Completion Date: April 2018
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165425


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Peter Mauch, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Andrea K. Ng, MD, Associate Professor of Radiation Oncology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165425     History of Changes
Other Study ID Numbers: 03-295
First Submitted: September 9, 2005
First Posted: September 14, 2005
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andrea K. Ng, MD, Dana-Farber Cancer Institute:
Cardiac screening
Cardiac stress test
Echocardiogram

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases