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Clinical Trials/NCT04072393
NCT04072393
Terminated
N/A

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

Washington University School of Medicine1 site in 1 country24 target enrollmentJanuary 15, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Washington University School of Medicine
Enrollment
24
Locations
1
Primary Endpoint
Feasibility of completing home-based CR after definitive radiation therapy in patients with thoracic cancer who have started the CR program
Status
Terminated
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 15, 2021
End Date
May 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Feasibility of home-based cardiac rehabiliation in all enrolled patients after definitive radiation therapy in patients with thoracic cancer.(Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months))

Study Sites (1)

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