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Exercise + Radiation Therapy for Prostate Cancer
N/A
Recruiting
Led By Nicholas Zaorsky, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to receive radiation therapy at University Hospitals Cleveland Medical Center or University Hospitals Lake Health Center
Patient receiving radiation dose of 20 Gray (Gy) in 5 fractions or stereotactic body radiation therapy (SBRT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month follow up
Awards & highlights
Study Summary
This trial is testing if adding personalized exercise to radiation therapy can improve quality of life and physical function after treatment, as well as if it can improve survival rates.
Who is the study for?
This trial is for men over 18 with metastatic prostate cancer undergoing their first round of palliative radiation therapy. They must have had hormone therapy, be in a stable condition (ECOG ≤3), and speak English. Exclusions include severe heart conditions, respiratory failure, high fracture risk, heavy current exercisers (>90 min/week), or those treated outside the specified hospitals.Check my eligibility
What is being tested?
The EXERT study tests if personalized exercise therapy during radiation treatment improves life quality and physical function in metastatic prostate cancer patients. It also examines whether exercise affects survival rates and correlates with inflammation markers in blood.See study design
What are the potential side effects?
While not drug-related, potential side effects from the intervention could include typical risks associated with exercise such as muscle strain or injury especially considering the patient's health status.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for radiation therapy at University Hospitals in Cleveland or Lake Health Center.
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I am receiving a specific radiation therapy dose or SBRT.
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I am a man over 18 receiving my first radiation treatment for spreading prostate cancer.
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I can care for myself but may not be able to do any physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health)
Secondary outcome measures
Aerobic Capacity: Six Minute Walk Test
Evaluation of symptomatic toxicity in study participants using the Common Terminology Criteria for Adverse Events- Patient Reported Outcomes (CTCAE-PRO)
Fatigue: Fatigue Symptom Inventory
+7 moreOther outcome measures
Barriers to Exercise RM 5-FM
Exploratory pro-inflammatory (IL-1B, IL-6, TNF-α, IL-8, IL-15, CRP) and anti-inflammatory (IL-10) markers
Work Productivity and Activity Impairment Questionnaire
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Radiation Therapy + Exercise TherapyExperimental Treatment1 Intervention
This group will receive exercise intervention in addition to their standard of care radiation treatment. At the baseline visit, they will meet with the certified exercise trainer (CET) and will be provided with a personalized exercise prescription and log to record what they do in between daily radiation treatment visits. The participant will also undergo an in-person exercise session prior to radiation therapy, which will take place either on the same day that the physical function tests are preformed or on a separate day. Participants will exercise between 1 and 7 times/week depending on the patient's tolerance to the exercise prescription. The CET will meet with the participant at every radiation treatment visit for an exercise counseling check-in. After five radiation treatments, the CET will follow-up with the participants via phone call once per week for 4 weeks during the follow-up period.
Group II: Radiation TherapyActive Control1 Intervention
The observational group will continue with their usual standard of care of radiation therapy. The study team will provide patients with an educational pamphlet at the end of their baseline visit. They will also be provided with a self-directed exercise program framework. Additionally, the participant's medical record will be reviewed for serious adverse events during their time on study. Baseline and final measurements will be obtained.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise therapy
2014
Completed Phase 3
~1220
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,762 Total Patients Enrolled
4 Trials studying Prostate Cancer
112 Patients Enrolled for Prostate Cancer
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,830 Total Patients Enrolled
32 Trials studying Prostate Cancer
3,113 Patients Enrolled for Prostate Cancer
Nicholas Zaorsky, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack or heart surgery in the last 6 months.I am a man aged 18 or older.I have experienced fainting spells.I have inflammation of the heart.I am getting radiation therapy at a place other than University Hospitals Cleveland or Lake Health Center.I am mentally capable of following the study's requirements.I have a health condition that could worsen with exercise or affect my ability to exercise.I am at high risk for bone fractures or spine instability.I am scheduled for radiation therapy at University Hospitals in Cleveland or Lake Health Center.I am receiving a specific radiation therapy dose or SBRT.My heart rhythm issue is under control and has been stable for over a month.I have received hormone therapy for my condition.I am hospitalized and receiving radiation for an urgent condition like cord compression, SVC syndrome, or brain metastases.I am a man over 18 receiving my first radiation treatment for spreading prostate cancer.I have had a recent lung clot or tissue death.I have had blood clots in my legs.I do not have severe heart failure.I am suspected to have a type of aneurysm that involves a tear in my artery wall.I have fluid in my lungs.I am experiencing severe difficulty breathing.I can care for myself but may not be able to do any physical work.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are current enrollees being sought out for this experiment?
"Regrettably, the information hosted on clinicaltrials.gov reveals this study is no longer open for recruitment - it was originally posted in February 1st 2023 and last updated August 2nd 2022. Nonetheless, there are currently 1258 other studies that need participants to join them."
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