Exercise Therapy in Radiation Therapy (EXERT)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Metastatic Cancer
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment- Emergent Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Kathleen Sturgeon
Assistant Professor
Milton S. Hershey Medical Center
Eligibility 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 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
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
- •acute myocarditis, pericarditis, or endocarditis
- •acute pulmonary embolus or pulmonary infarction
Outcomes
Primary Outcomes
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
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)
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)
Secondary Outcomes
- change in quality of life measured via the Godin Physical Activity Questionnaire(3 Months)
- change in quality of life measured via the Barriers to Exercise RM 5-FM survey(3 Months)
- change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment(3 Months)
- Change in timed up and go(3 Months)
- change in quality of life measured via the Health Belief Scale(3 Months)
- change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire(3 Months)
- change in quality of life measured via the EORTC questionnaire(3 Months)
- change in grip strength(3 Months)
- change in quality of life measured via the ECHO EXERT survey(3 Months)