Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers
Key facts
- Who runs it
- Washington University School of Medicine
- Where
- St Louis, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 24 people enrolled
- Started
- 15 Jan 2021
- Ended
- 15 May 2024
- Type of study
- Interventional
- Treatments tested
- Home-based cardiac rehabilitation
- Record updated
- 12 July 2024
- Why it stopped
- Futility
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Presence of distant metastatic disease (except patients with lymphoma)
- 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
- 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
- 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
Where in United States
- Washington University School of MedicineSt Louis, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Home-based cardiac rehabilitationTreatment being tested
* 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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Trial of Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers
- Record updated
- 12 July 2024