Exercise Therapy in Radiation Therapy

Metastatic Cancer Clinical Trial

— EXERT  

Official title:

Exercise Therapy in Radiation Therapy (EXERT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905356
• Other study ID #: STUDY00010618
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 31, 2023
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Behavioral:
• Exercise Therapy
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.

Locations

Country	Name	City	State
United States	Penn State Cancer Institute	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached)	(number of patients agreeing to perform RT+ET)/(number approached)	1 year
Primary	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)	1 year
Primary	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	1 year
Secondary	Change in timed up and go	Timed up and go	3 Months
Secondary	change in grip strength	Grip strength	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months
Secondary	change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire	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.	3 Months
Secondary	change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment	The Score Patient-Generated Subjective Global Assessment asks about participant nutrition. A variety of question/response styles are included in the survey.	3 Months
Secondary	change in quality of life measured via the EORTC questionnaire	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.	3 Months
Secondary	change in quality of life measured via the ECHO EXERT survey	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.	3 Months
Secondary	change in quality of life measured via the Health Belief Scale	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.	3 Months