TerminatedNot applicableNCT04072393
Official study title

Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers

Study summary

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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedHome-based cardiac rehabilitation

The study team can explain what participation involves.

Who it may be forLung Cancer · Esophageal Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 12, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Washington University School of Medicine

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Washington University School of Medicine
Interventions being studied
Procedure: Home-based cardiac rehabilitation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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).
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Washington University School of MedicineSt Louis, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 12, 2024. Always confirm current availability with the study team.

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