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Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is being done to determine if patients receiving personalized exercise therapy (versus those who do not receive personalized exercise therapy) have improved quality of life and physical functioning after completing their radiation therapy. Second, the study is being done to find if the quality of life changes during therapy correlate with measurements of inflammation in the blood. Third, the study is being done to see if adding exercise therapy to radiation therapy will improve survival.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects must have lymph node positive or metastatic disease consistent with prostate cancer

• Males ≥18 years of age receiving RT

• Patient receiving 5 fractions or stereotactic body radiation therapy (SBRT)

• Patient may have received prior hormone therapy. Prior or current use of chemotherapy agents is allowed, but not necessary.

• Fluent in written and spoken English

• Must be able to provide and understand informed consent

• Must have an ECOG Performance Status (PS) of ≤ 3

• Primary attending radiation oncologist approval

Locations
United States
Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Nicholas G Zaorsky, MD, MS
Nicholas.Zaorsky@uhhospitals.org
1-800-641-2422
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 80
Treatments
Experimental: Radiation Therapy + Exercise Therapy
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.
No_intervention: Radiation Therapy
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.
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov

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