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Metastatic CancerEXERTNCT03905356

Exercise Therapy in Radiation Therapy

A study testing Exercise Therapy in people with Metastatic Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer
What is being tested?
Exercise Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
12 Feb 2020to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Exercise Therapy in Radiation Therapy (EXERT)

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.

Read the 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.

Being tested
Exercise Therapy
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise TherapyBehavioural

    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.

Study groups in NCT03905356
Study groupRoleWhat they receive
ExerciseExperimentalThe 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).
Receives: Behavioral: Exercise Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 1 year

  2. 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)

    Measured: 1 year

  3. 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

    Measured: 1 year

Secondary outcomes (9)

  1. Change in timed up and go

    Timed up and go

    Measured: 3 Months

  2. change in grip strength

    Grip strength

    Measured: 3 Months

  3. 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.

    Measured: 3 Months

  4. 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.

    Measured: 3 Months

  5. 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.

    Measured: 3 Months

  6. 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.

    Measured: 3 Months

  7. 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.

    Measured: 3 Months

  8. 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.

    Measured: 3 Months

  9. 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.

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2019
  2. Study start12 Feb 2020
  3. Primary completion26 Jan 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03905356
Sponsor's protocol ID
STUDY00010618
Acronym
EXERT
Status last verified
May 2023
First submitted
28 Mar 2019
Last updated
6 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Therapy in people with Metastatic Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of exercise intervention: (number of patients agreeing to perform RT+ET)/(number approached) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03905356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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