Back to results

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

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

NCT ID

NCT04072393

First Posted

August 26, 2019

Last Updated

August 3, 2023

Sponsor

Washington University School of Medicine

Collaborators

The Foundation for Barnes-Jewish Hospital

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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

Links:

URL

http://www.siteman.wustl.edu

Description

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

Learn more about this trial

Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers

We'll reach out to this number within 24 hrs