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Exercise Therapy in Radiation Therapy (EXERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905356
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Nicholas Zaorsky, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to evaluate exercise therapy as a method for potentially improving radiation therapy treatment toxicities for metastatic cancer patients receiving radiation therapy.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Behavioral: Exercise Therapy Not Applicable

Detailed Description:

Study Objectives and Endpoints:

Aim 1. To determine the acceptability, feasibility, and safety of an exercise intervention among cancer patients receiving radiation therapy. The investigators anticipate that >25% of approached patients will consent to the protocol; >33% of eligible radiation therapy patients who consent will perform the exercise prescribed (based on the response rate from EnACT); and <25% of participants will experience a musculoskeletal impairment (without treatment alterations) and <5% will experience a musculoskeletal injury with symptoms lasting ≥ week or requiring medical attention. The investigators' approach will be to include patients receiving definitive RT; excluding patients at high risk for side effects from combination therapy, including fracture or cardiovascular events.

Aim 2. To discern the clinical outcomes of patients receiving RT+ET. The hypothesis is that adding ET to RT will improve patient reported outcomes and physical functioning. The investigators' approach will be to use standardized questionnaires and assessment tools: patient reported outcomes will be assessed using Common Terminology Criteria for Adverse Events - Patient Reported Outcomes (CTCAE-PROs), loaded onto tablets that patients use in the clinic. Questions will assess global PROs relevant to the ability to tolerate RT, including fatigue, pain, nausea, vomiting; and disease-site-specific PROs, including genitourinary/sexual symptoms for patients receiving pelvic RT. RT dose alterations will be documented. Scores will be compared pre- vs post- RT. The investigators will also use standardized measures already used in EnACT, including grip strength, 30-second chair stand, timed up-and-go, and 4-stage balance. Scores will be compared pre- vs post- RT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise Therapy in Radiation Therapy (EXERT)
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
The exercise intervention will utilize the "Moving Through Cancer: A Guide to Exercise for Cancer Survivors" framework. A certified cancer exercise physiologist will work through this guide at radiation therapy visits, with at least 1 visit per week, per the study schema. The cancer exercise physiologist will teach participants proper: warm ups, use of equipment, exercise form, modes of activity, intensity of exercise, flexibility exercises, and cool down. The cancer exercise physiologist will tailor the instruction to convey special considerations for exercise based on treatment and cancer type. The patient will perform supervised exercise in the Exercise Medicine Unit under the guidance of the cancer exercise specialist. The exercise done will be educational in nature (i.e. learning about proper walking form, proper intensity for a warmup/cool down, proper techniques for resistance exercises).
Behavioral: Exercise Therapy
Certified exercise oncology specialists will personalize, prescribe, and guide ET, including twice weekly resistance training and walking, performed at home, with supervision in the Exercise Medicine Unit. The cancer exercise physiologist will teach participants proper warm ups, use of equipment, exercise form, modes of activity, intensity of exercise, flexibility exercises, and cool down. In addition, patients will be instructed to exercise on their own, at home, according to the instructions from the cancer exercise specialist.




Primary Outcome Measures :
  1. Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached) [ Time Frame: 1 year ]
    (number of patients agreeing to perform RT+ET)/(number approached)

  2. Feasibility of exercise intervention: (number of patients who completed RT+ET)/(number agreeing to perform RT+ET) [ Time Frame: 1 year ]
    (number of patients who completed RT+ET)/(number agreeing to perform RT+ET)

  3. Incidence of Treatment- Emergent Adverse Events [ Time Frame: 1 year ]
    Safety of exercise intervention: freedom from any Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher event


Secondary Outcome Measures :
  1. Change in timed up and go [ Time Frame: 3 Months ]
    Timed up and go

  2. change in grip strength [ Time Frame: 3 Months ]
    Grip strength

  3. change in quality of life measured via the Godin Physical Activity Questionnaire [ Time Frame: 3 Months ]
    The Godin Physical Activity Questionnaire asks how much physical activity the participant engages in during a typical 7-day period.

  4. change in quality of life measured via the Barriers to Exercise RM 5-FM survey [ Time Frame: 3 Months ]
    The Barriers to Exercise RM 5-FM survey asks participants about barriers to being active. Response options include: very likely; somewhat likely; somewhat unlikely; very unlikely.

  5. change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire [ Time Frame: 3 Months ]
    The Work Productivity and Activity Impairment Questionnaire ask about the effect of the participant's health problems on the ability to work and perform regular activities. A variety of question/response styles are included in the survey.

  6. change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment [ Time Frame: 3 Months ]
    The Score Patient-Generated Subjective Global Assessment asks about participant nutrition. A variety of question/response styles are included in the survey.

  7. change in quality of life measured via the EORTC questionnaire [ Time Frame: 3 Months ]
    The EORTC Quality of life questionnaire asks a variety of questions about their health regarding physical abilities. Response options include: not at all; a little; quite a bit; very much.

  8. change in quality of life measured via the ECHO EXERT survey [ Time Frame: 3 Months ]
    The Experience of Care and Health Outcomes (ECHO) Survey asks three questions about participant experience with the exercise intervention. Response options include: not at all; not much; mixed; somewhat; very much so.

  9. change in quality of life measured via the Health Belief Scale [ Time Frame: 3 Months ]
    The Health Belief Scale asks questions regarding exercise therapy. Response options include: strongly disagree - strongly agree, where 1 equals strongly disagree and 4 equals strongly agree.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Males and females ≥18 years of age
  • Fluent in written and spoken English
  • Must be able to provide and understand informed consent
  • Must have an ECOG PS of ≤ 2
  • Diagnosed with a malignancy
  • Cancer patients (stage 1-4)
  • Treatment to primary site or metastatic disease
  • Scheduled to receive radiation therapy at Penn State Cancer Institute
  • Absence of absolute contraindications for exercise according to the American Heart Association (see below)
  • Primary attending oncologist approval
  • Receiving treatment as an outpatient

Exclusion Criteria:

  • Receiving radiation therapy at a location other than Penn State Cancer Institute
  • Not fluent in written and spoken English
  • Evidence in the medical record of an absolute contraindication for exercise
  • Cardiac exclusion criteria:

    • Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
    • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of radiation therapy
    • Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for >1 month prior to start of radiation therapy may be eligible
    • syncope
    • acute myocarditis, pericarditis, or endocarditis
    • acute pulmonary embolus or pulmonary infarction
    • thrombosis of lower extremities
    • suspected dissecting aneurysm
    • pulmonary edema
    • respiratory failure
    • acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
    • mental impairment leading to inability to cooperate
  • Pregnant women
  • In-patient receiving radiation therapy for a radiation emergency (e.g. cord compression, SVC syndrome, brain metastases)
  • High risk of fracture or spine instability (Mirels score ≥7, SINS ≥7)
  • Children (the protocol will only include individuals 18 and older)

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): NCT03905356


Contacts
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Contact: Nicholas G Zaorsky, MD 1-717-531-8024 nzaorsky@pennstatehealth.psu.edu
Contact: Kelsey C Stoltzfus, MPH 717-531-0003 ext 289496 kstoltzfus4@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Nicholas G Zaorsky, MD    717-531-8024    nzaorsky@pennstatehealth.psu.edu   
Contact: Erica Schleicher, MS    717-531-0003 ext 323324    eschleicher1@phs.psu.edu   
Principal Investigator: Nicholas G Zaorsky, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Nicholas G Zaorsky, MD Penn State Cancer Institute
Study Chair: Kathryn Schmitz, MD Penn State Cancer Institute
  Study Documents (Full-Text)

Documents provided by Nicholas Zaorsky, Milton S. Hershey Medical Center:
Informed Consent Form  [PDF] January 15, 2018

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Responsible Party: Nicholas Zaorsky, Assistant Professor, Department of Radiation Oncology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03905356    
Other Study ID Numbers: STUDY00010618
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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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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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes