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Cardiac Rehabilitation for Patients With Lung or Esophageal Cancer Receiving Definitive Radiation Therapy

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ClinicalTrials.gov Identifier: NCT04072393
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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) who are not receiving cardiotoxic chemotherapies, such as patients with lung and esophageal cancers, is unknown. In addition, cardiac rehabilitation has not been tested in patients with lung or esophageal cancers.

Condition or disease Intervention/treatment Phase
Lung Cancer Esophageal Cancer Procedure: Cardiac rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Trial of Cardiac Rehabilitation for Patients With Lung or Esophageal Cancer Receiving Definitive Radiation Therapy
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : April 30, 2021


Arm Intervention/treatment
Experimental: Cardiac rehabilitation
  • The intervention consists of a prescribed course of cardiac rehabilitation: 36 sessions, three times a week, one hour each, over a period of 8 to 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
Procedure: Cardiac rehabilitation
- Within 6 weeks of completion of standard of care radiation therapy patients, will be evaluated by the clinical team at The Heart Care Institute at Barnes-Jewish West County Hospital and begin a prescribed course of cardiac rehabilitation.




Primary Outcome Measures :
  1. Feasibility of cardiac rehabilitation after definitive radiation therapy as measured by number of participants who complete at least 75% of prescribed cardiac rehabilitation sessions [ Time Frame: Through completion of cardiac rehabilitation for all patients enrolled (estimated to be 15 months) ]
    -Cardiac rehabilitation will be considered as feasible if 75% of participants enrolled participate in at least 75% of prescribed cardiac rehabilitation sessions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed or radiographically-apparent stage IA1-IIIC non-small cell or small cell carcinoma of the lung OR pathologically confirmed stage I-IVA thoracic esophagus or esophagogastric junction cancer.
  • Planning to receive definitive radiation therapy with curative intent.
  • Not a surgical candidate as determined by a surgeon or at multi-disciplinary tumor conference.
  • Willing to participate in the Cardiac Rehabilitation program at BJC/Washington University School of Medicine Heart Care Institute on the campus of Barnes-Jewish West County Hospital.
  • 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.
  • Presence of significant cancer disease burden that would make patient unlikely to tolerate cardiac rehabilitation.
  • Diagnosis of primary cervical esophageal cancer.
  • Prior or planned treatment with anthracyclines or anti-Her2 directed agents.
  • Presence of stable or unstable angina.
  • History of myocardial infarction, coronary artery bypass graft, or percutaneous coronary vascular intervention in the preceding 12 months.
  • Recipient of heart transplant.
  • 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 Cardiac Rehab program or other assessments involved with this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072393


Contacts
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Contact: Shahed Badiyan, M.D. 314-273-2931 sbadiyan@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Shahed Badiyan, M.D.    314-273-2931    sbadiyan@wustl.edu   
Principal Investigator: Shahed Badiyan, M.D.         
Sub-Investigator: Linda R Peterson, M.D.         
Sub-Investigator: Daniel J Lenihan, M.D.         
Sub-Investigator: Cliff G Robinson, M.D.         
Sub-Investigator: Matthew Spraker, MD., Ph.D.         
Sub-Investigator: Aadel Chaudhuri, M.D., Ph.D.         
Sub-Investigator: Greg Vlacich, M.D., Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Shahed Badiyan, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04072393     History of Changes
Other Study ID Numbers: 19-x293
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases