Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04072393
• Other study ID #: 201909133
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Carmen Bergom, M.D., Ph.D.
• Phone: 314-747-1786
• Email: cbergom[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Esophageal Cancer
• Hodgkin Disease
• Hodgkin Lymphoma
• Lung Cancer
• Lymphoma
• Non-hodgkin Lymphoma
• Sarcoma
• Thoracic Cancer
• Thoracic Neoplasms
• Thymoma

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of completing home-based CR after definitive radiation therapy in patients with thoracic cancer who have started the CR program	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	Feasibility of home-based cardiac rehabiliation in all enrolled patients after definitive radiation therapy in patients with thoracic cancer.	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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine