Prostate Cancer Clinical Trial
Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer
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.
Full Description
In 2018, 30,000 patients were diagnosed metastatic prostate cancer in the US. Short-course radiation therapy (RT) is a mainstay of treatment for symptomatic metastases, and it stimulates an immune response against the tumor. However, RT also decreases systemic interleukin-1 receptor antagonist (IL-1Ra), placing the body in a pro-inflammatory state, and increasing fatigue and reducing quality of life (QOL). Fatigue and QOL are surrogates of the limited 2-20 month survival time. If fatigue and quality of life are improved, then toxicity and survival will follow.
Our long-term goal is to identify the potential for exercise therapy (ET) to improve RT treatment toxicities and outcomes among metastatic cancer patients. The mechanistic hypothesis is that adding ET training to RT decreases long-term systemic inflammation, mitigating toxicity thereby widening the therapeutic window.
Objective 1. Quantify the potential of Exercise Therapy (ET) to mitigate Radiation Treatment (RT) toxicities and physical function decline. The hypothesis is that ET mitigates patient-reported quality of life (QOL) and toxicities of RT. Our approach will be to use standardized questionnaires and assessment tools to assess QOL and physical function.
Objective 2. Characterize the immunologic mechanism by which ET mitigates RT toxicity. The hypothesis is that ET mitigates the toxicity of RT (measured in objective 1) by increasing serum interleukin-1Ra (IL-1Ra).
Objective 3. Evaluate the ability of ET to improve survival. Since physical function is a surrogate of survival, the hypothesis is that adding ET to RT will improve overall survival, measured from the date of start of radiotherapy until death.
Eligibility Criteria
Inclusion Criteria:
Subjects must have metastatic disease consistent with prostate cancer
Males ≥18 years of age receiving first palliative course of RT for metastatic prostate cancer
Patient receiving radiation dose of 20 Gray (Gy) in 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
Scheduled to receive radiation therapy at University Hospitals Cleveland Medical Center or University Hospitals Lake Health Center
Primary attending radiation oncologist approval
Exclusion Criteria:
Receiving radiation therapy at a location other than University Hospitals Cleveland Medical Center or University Hospitals Lake Health Center
Performing > 90 minutes/week of exercise therapy prior at time of enrollment
Evidence in the medical record of an absolute contraindication for exercise
Cardiac exclusion criteria:
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)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Cleveland Ohio, 44106, United States
How clear is this clinincal trial information?