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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)

Must not have

Syncope

Children (the protocol will only include men age 18 and older)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month follow up

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have experienced fainting spells.

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I am a man aged 18 or older.

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I have inflammation of the heart.

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I am getting radiation therapy at a place other than University Hospitals Cleveland or Lake Health Center.

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I am mentally capable of following the study's requirements.

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I am at high risk for bone fractures or spine instability.

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I am hospitalized and receiving radiation for an urgent condition like cord compression, SVC syndrome, or brain metastases.

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I have had a recent lung clot or tissue death.

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I have had blood clots in my legs.

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I do not have severe heart failure.

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I am suspected to have a type of aneurysm that involves a tear in my artery wall.

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I have fluid in my lungs.

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I am experiencing severe difficulty breathing.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health)

Secondary study objectives

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 more

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

N/A

~1240

0 / 17Eligibility criteria met