Exercise Therapy in Radiation Therapy

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.

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)