Exercise Therapy in Radiation Therapy

Not Applicable

Completed

• Conditions: Metastatic Cancer

• Registration Number: NCT03905356
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-05
• Study Start: 2020-02-12
• Primary Completion: 2022-01-26
• Study Completion: 2023-01-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment- Emergent Adverse Events	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)	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)	1 year	(number of patients who completed RT+ET)/(number agreeing to perform RT+ET)

Secondary Outcome Measures

Name	Time	Method
change in quality of life measured via the Godin Physical Activity Questionnaire	3 Months	The Godin Physical Activity Questionnaire asks how much physical activity the participant engages in during a typical 7-day period.
change in quality of life measured via the Barriers to Exercise RM 5-FM survey	3 Months	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.
change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment	3 Months	The Score Patient-Generated Subjective Global Assessment asks about participant nutrition. A variety of question/response styles are included in the survey.
Change in timed up and go	3 Months	Timed up and go
change in quality of life measured via the Health Belief Scale	3 Months	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.
change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire	3 Months	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.
change in quality of life measured via the EORTC questionnaire	3 Months	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.
change in quality of life measured via the ECHO EXERT survey	3 Months	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.
change in grip strength	3 Months	Grip strength

Trial Locations

Locations (1)

Penn State Cancer Institute; 🇺🇸 Hershey, Pennsylvania, United States