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

Status: Terminated
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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).

Locations
United States
Missouri
Washington University School of Medicine
Saint Louis
Time Frame
Start Date: 2021-01-15
Completion Date: 2024-05-15
Participants
Target number of participants: 24
Treatments
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.
Sponsors
Leads: Washington University School of Medicine
Collaborators: The Foundation for Barnes-Jewish Hospital

This content was sourced from clinicaltrials.gov