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Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers

Primary Purpose

Lung Cancer, Esophageal Cancer, Thoracic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based cardiac rehabilitation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based cardiac rehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 26, 2019
Last Updated
August 3, 2023
Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04072393
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Esophageal Cancer, Thoracic Cancer, Hodgkin Lymphoma, Hodgkin Disease, Non-hodgkin Lymphoma, Sarcoma, Thymoma, Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based cardiac rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Home-based cardiac rehabilitation
Intervention Description
-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.
Primary Outcome Measure Information:
Title
Feasibility of completing home-based CR after definitive radiation therapy in patients with thoracic cancer who have started the CR program
Description
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.
Time Frame
Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)
Secondary Outcome Measure Information:
Title
Feasibility of home-based cardiac rehabiliation in all enrolled patients after definitive radiation therapy in patients with thoracic cancer.
Description
Feasibility is defined as 75% of all enrolled patients of cardiac rehabilitation participating in at least 75% of prescribed home-based CR sessions.
Time Frame
Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 36 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Bergom, M.D., Ph.D.
Phone
314-747-1786
Email
cbergom@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Bergom, M.D., Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Bergom, M.D., Ph.D.
Phone
314-747-1786
Email
cbergom@wustl.edu
First Name & Middle Initial & Last Name & Degree
Carmen Bergom, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Linda R Peterson, M.D.
First Name & Middle Initial & Last Name & Degree
Joshua Mitchell, M.D.
First Name & Middle Initial & Last Name & Degree
Cliff G Robinson, M.D.
First Name & Middle Initial & Last Name & Degree
Aadel Chaudhuri, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Greg Vlacich, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Pamela Samson, M.D.
First Name & Middle Initial & Last Name & Degree
Yi Huang, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers

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