Clinical trial NCT03905356: Exercise Therapy in Radiation Therapy
Official title: Exercise Therapy in Radiation Therapy (EXERT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Cancer
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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)

Primary outcomes:
measure: Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached)
timeFrame: 1 year
measure: Feasibility of exercise intervention: (number of patients who completed RT+ET)/(number agreeing to perform RT+ET)
timeFrame: 1 year
measure: Incidence of Treatment- Emergent Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: Change in timed up and go
timeFrame: 3 Months
measure: change in grip strength
timeFrame: 3 Months
measure: change in quality of life measured via the Godin Physical Activity Questionnaire
timeFrame: 3 Months
measure: change in quality of life measured via the Barriers to Exercise RM 5-FM survey
timeFrame: 3 Months
measure: change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire
timeFrame: 3 Months
measure: change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment
timeFrame: 3 Months
measure: change in quality of life measured via the EORTC questionnaire
timeFrame: 3 Months
measure: change in quality of life measured via the ECHO EXERT survey
timeFrame: 3 Months
measure: change in quality of life measured via the Health Belief Scale
timeFrame: 3 Months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Kathleen Sturgeon, PhD
role: PRINCIPAL_INVESTIGATOR
References: