- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03905356
Exercise Therapy in Radiation Therapy (EXERT)
Exercise Therapy in Radiation Therapy (EXERT)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 metastatic disease
- 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
- Performing > 90 minutes/week of physical activity at the time of initial evaluation
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached)
Time Frame: 1 year
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(number of patients agreeing to perform RT+ET)/(number approached)
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1 year
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Feasibility of exercise intervention: (number of patients who completed RT+ET)/(number agreeing to perform RT+ET)
Time Frame: 1 year
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(number of patients who completed RT+ET)/(number agreeing to perform RT+ET)
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1 year
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Incidence of Treatment- Emergent Adverse Events
Time Frame: 1 year
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Safety of exercise intervention: freedom from any Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher event
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in timed up and go
Time Frame: 3 Months
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Timed up and go
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3 Months
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change in grip strength
Time Frame: 3 Months
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Grip strength
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3 Months
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change in quality of life measured via the Godin Physical Activity Questionnaire
Time Frame: 3 Months
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The Godin Physical Activity Questionnaire asks how much physical activity the participant engages in during a typical 7-day period.
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3 Months
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change in quality of life measured via the Barriers to Exercise RM 5-FM survey
Time Frame: 3 Months
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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.
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3 Months
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change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire
Time Frame: 3 Months
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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.
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3 Months
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change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment
Time Frame: 3 Months
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The Score Patient-Generated Subjective Global Assessment asks about participant nutrition.
A variety of question/response styles are included in the survey.
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3 Months
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change in quality of life measured via the EORTC questionnaire
Time Frame: 3 Months
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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.
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3 Months
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change in quality of life measured via the ECHO EXERT survey
Time Frame: 3 Months
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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.
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3 Months
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change in quality of life measured via the Health Belief Scale
Time Frame: 3 Months
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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.
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3 Months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathleen Sturgeon, PhD, Penn State College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00010618
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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