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Exercise Therapy in Radiation Therapy (EXERT)

Primary Purpose

Metastatic Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Therapy

About this trial

This is an interventional supportive care trial for Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Penn State Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

The exercise intervention will utilize the "Moving Through Cancer: A Guide to Exercise for Cancer Survivors" framework. A certified cancer exercise physiologist will work through this guide at radiation therapy visits, with at least 1 visit per week, per the study schema. 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. The cancer exercise physiologist will tailor the instruction to convey special considerations for exercise based on treatment and cancer type. The patient will perform supervised exercise in the Exercise Medicine Unit under the guidance of the cancer exercise specialist. The exercise done will be educational in nature (i.e. learning about proper walking form, proper intensity for a warmup/cool down, proper techniques for resistance exercises).

Outcomes

Primary Outcome Measures

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

(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)

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

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

Secondary Outcome Measures

Change in timed up and go

Timed up and go

change in grip strength

Grip strength

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03905356

First Posted

March 28, 2019

Last Updated

May 3, 2023

Sponsor

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03905356

Brief Title

Exercise Therapy in Radiation Therapy

Acronym

EXERT

Official Title

Exercise Therapy in Radiation Therapy (EXERT)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

February 12, 2020 (Actual)

Primary Completion Date

January 26, 2022 (Actual)

Study Completion Date

January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 year

Title

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

Description

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

Time Frame

1 year

Title

Incidence of Treatment- Emergent Adverse Events

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Change in timed up and go

Description

Timed up and go

Time Frame

3 Months

Title

change in grip strength

Description

Grip strength

Time Frame

3 Months

Title

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

Description

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

Time Frame

3 Months

Title

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

Description

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

Title

change in quality of life measured via the Work Productivity and Activity Impairment Questionnaire

Description

Time Frame

3 Months

Title

change in quality of life measured via the Scored Patient-Generated Subjective Global Assessment

Description

The Score Patient-Generated Subjective Global Assessment asks about participant nutrition. A variety of question/response styles are included in the survey.

Time Frame

3 Months

Title

change in quality of life measured via the EORTC questionnaire

Description

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.

Time Frame

3 Months

Title

change in quality of life measured via the ECHO EXERT survey

Description

Time Frame

3 Months

Title

change in quality of life measured via the Health Belief Scale

Description

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.

Time Frame

3 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Sturgeon, PhD

Organizational Affiliation

Penn State College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Cancer Institute

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Exercise Therapy in Radiation Therapy

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