Exercise Therapy in Radiation Therapy

Milton S. Hershey Medical Center16 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Metastatic Cancer

Interventions

Exercise TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached)

(number of patients agreeing to perform RT+ET)/(number approached)

Time frame: 1 year

Feasibility of exercise intervention: (number of patients who completed RT+ET)/(number agreeing to perform RT+ET)

(number of patients who completed RT+ET)/(number agreeing to perform RT+ET)

Time frame: 1 year

Incidence of Treatment- Emergent Adverse Events

Safety of exercise intervention: freedom from any Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher event

Time frame: 1 year

Secondary Outcomes

Change in timed up and go

Timed up and go

Time frame: 3 Months

change in grip strength

Grip strength

Time frame: 3 Months

change in quality of life measured via the Godin Physical Activity Questionnaire

The Godin Physical Activity Questionnaire asks how much physical activity the participant engages in during a typical 7-day period.

Time frame: 3 Months

change in quality of life measured via the Barriers to Exercise RM 5-FM survey

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.

Time frame: 3 Months

Data from ClinicalTrials.gov

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