Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer
Case Comprehensive Cancer Center
80 participants
Dec 11, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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
Exclusion Criteria17
- Performing \> 90 minutes/week of exercise therapy prior at time of enrollment
- Evidence in the medical record of an absolute contraindication for exercise
- 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 complete study requirements
- In-patient receiving radiation therapy for a radiation emergency (e.g. cord compression, Superior vena cava (SVC) syndrome, brain metastases)
- High risk of fracture or spine instability (Mirels score ≥7, SINS ≥7)
- Children (the protocol will only include men age 18 and older)
Interventions
The exercise therapy intervention will last 4 weeks. Each participant assigned to this intervention will receive a personalized ET regimen, including in-person, supervised exercise sessions; other activities to be followed at home. Participants will exercise between one and seven times per week depending on their tolerance to the treatment and exercise program.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04556045