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

Primary Purpose

Hodgkin's Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echo/Stress Echo
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hodgkin's Disease focused on measuring Cardiac screening, Cardiac stress test, Echocardiogram

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac screening

Arm Description

Interventions: Participants will meet with study cardiologist undergo cardiac risk factors screening undergo resting and stress echocardiogram (echo and stress echo)

Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
June 21, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00165425
Brief Title
Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation
Official Title
Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Disease
Keywords
Cardiac screening, Cardiac stress test, Echocardiogram

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac screening
Arm Type
Experimental
Arm Description
Interventions: Participants will meet with study cardiologist undergo cardiac risk factors screening undergo resting and stress echocardiogram (echo and stress echo)
Intervention Type
Procedure
Intervention Name(s)
Echo/Stress Echo
Intervention Description
Participants will under resting echocardiogram and stress echocardiogram (echo and stress echo) and the results will be interpreted by a cardiologist
Primary Outcome Measure Information:
Title
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.
Description
Compliance of screening and follow up visits are tracked
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To prospectively collect data on the prevalence of modifiable cardiac risk factors and the spectrum of cardiac structural abnormalities in this patient populations
Description
Data on modifiable cardiac risk factors, and outcome of screening studies, are collected prospectively
Time Frame
3 years
Title
to correlate cardiac structural abnormalities with quality of life
Description
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
Time Frame
3 years
Title
to correlate cardiac structural abnormalities with level of fatigue.
Description
Responses to the fatigue subscale of FACT-Fatigue (FACT-F), collected at the time of initial visit, will be correlated with cardiac screening results
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Mauch, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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