Clinical trial NCT04072393: Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers
Official title: A Pilot Trial of Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Esophageal Cancer
Thoracic Cancer
Hodgkin Lymphoma
Hodgkin Disease
Non-hodgkin Lymphoma
Sarcoma
Thymoma
Breast Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
First posted: 2019-08-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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)
* 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.

Primary outcomes:
measure: Feasibility of completing home-based CR after definitive radiation therapy in patients with thoracic cancer who have started the CR program
timeFrame: Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)
Secondary outcomes:
measure: Feasibility of home-based cardiac rehabiliation in all enrolled patients after definitive radiation therapy in patients with thoracic cancer.
timeFrame: Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Carmen Bergom, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: