Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers

February 7, 2024 updated by: Washington University School of Medicine

A Pilot Trial of Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers

Other than optimizing medical management of cardiac risk factors, and reducing radiotherapy (RT) dose to the heart, there currently exist no interventions to mitigate or reverse the adverse cardiac effects of RT. Aerobic exercise has been demonstrated to improve patient quality of life, cardiac outcomes, and cardiorespiratory fitness in patients with cancer receiving cardiotoxic systemic therapies, but the effects of aerobic exercise on patients at high risk for radiation induced heart disease (RIHD) is unknown. In addition, home-based cardiac rehabilitation has not been tested in patients with thoracic cancers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carmen Bergom, M.D., Ph.D.
  • Phone Number: 314-747-1786
  • Email: cbergom@wustl.edu

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Linda R Peterson, M.D.
        • Sub-Investigator:
          • Joshua Mitchell, M.D.
        • Sub-Investigator:
          • Cliff G Robinson, M.D.
        • Sub-Investigator:
          • Pamela Samson, M.D.
        • Sub-Investigator:
          • Aadel Chaudhuri, M.D., Ph.D.
        • Sub-Investigator:
          • Yi Huang, Ph.D.
        • Contact:
        • Principal Investigator:
          • Carmen Bergom, M.D., Ph.D.
        • Sub-Investigator:
          • Greg Vlacich, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically confirmed or radiographically diagnosed non-small cell lung cancer, small cell lung cancer, esophageal cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, sarcoma, thymoma, or left-sided breast cancer.
  • Planning to receive neo-adjuvant, adjuvant, or definitive radiation therapy to the thorax with curative intent.
  • Willing to participate in home-based cardiac rehabilitation program and be monitored remotely via smart phone application
  • Possess a smart phone or tablet capable of supporting teleHeart application
  • Willing and eligible to co-enroll in the Cardiovascular Toxicity in Cancer and Improvement in Recovery (SURVIVE) Registry Study (HRPO# 201801031).
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Presence of distant metastatic disease (except patients with lymphoma).
  • Life expectancy less than 6 months
  • Patient lives in skilled nursing facility, chronic care facility, nursing home, or palliative care or hospice facility
  • Unable to walk
  • Presence of significant cancer disease burden that would make patient unlikely to tolerate cardiac rehabilitation (CR)
  • Diagnosis of primary cervical esophageal cancer.
  • Presence of unstable angina.
  • Recipient of heart transplant.
  • Patient on cardiac transplant list or has a ventricular assist device
  • Patient's baseline weight > 300 lbs (due to weight limitations of the scale and bioelectrical impedance device)
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Other medical comorbidities that make the patient unable to participate in the CR program or other assessments involved with this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based cardiac rehabilitation
  • The intervention consists of a prescribed course of home-based cardiac rehabilitation: 36 sessions, three times a week, one hour each, over a period of 12 weeks.

  • Each customized exercise session includes three phases:

    • a 5- to 10-minute warm-up which consists of stretching, flexibility movements, and aerobic activity which gradually raises the heart rate to the desired level
    • a conditioning or training phase, which consists of 20 to 45 minutes of continuous or discontinuous aerobic activity
    • a cool down for 5 to 10 minutes consisting of low-intensity exercise that permits a gradual recovery from the conditioning phase
  • The patient will complete a brief questionnaire on the teleHeart application after completing each exercise session on how well they tolerated the exercise. The patient's CR team will receive daily updates from the patient's teleHeart application. Based on feedback from the application, the CR team may modify the patient's exercise program going forward.
Procedure: Home-based cardiac rehabilitation
-Patients will be evaluated by the clinical team at The Heart Care Institute (HCI). They will receive a heart rate monitor, blood pressure monitor, and weight scale that they will take home with them. They will receive training on how to use the heart rate monitor and blood pressure monitor. They will receive training on how to record their exercises and weights in the teleHeart application by an exercise physiologist from HCI. Within 6 weeks of completion of standard of care radiation therapy or cytotoxic chemotherapy (whichever is last), they will be prescribed a course of home-based CR by a cardiologist at HCI and be instructed on the regimen by an exercise physiologist from HCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of completing home-based CR after definitive radiation therapy in patients with thoracic cancer who have started the CR program
Time Frame: Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)
Feasibility of completion is defined as 75% of patients who start their first session of cardiac rehabilitation participating in at least 75% of prescribed home-based CR exercise sessions.
Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of home-based cardiac rehabiliation in all enrolled patients after definitive radiation therapy in patients with thoracic cancer.
Time Frame: Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)
Feasibility is defined as 75% of all enrolled patients of cardiac rehabilitation participating in at least 75% of prescribed home-based CR sessions.
Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

The Foundation for Barnes-Jewish Hospital

Investigators

  • Principal Investigator: Carmen Bergom, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201909133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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