Exercise therapy combined with radiation for metastatic prostate cancer
Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer
This study tests if adding personalized exercise therapy to radiation treatment can help men with metastatic prostate cancer feel better and improve their physical health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04556045 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of personalized exercise therapy on the quality of life and physical functioning of patients undergoing radiation therapy for metastatic prostate cancer. It will assess whether exercise therapy can mitigate the toxicities associated with radiation treatment and improve overall survival. The study will utilize standardized questionnaires and assessment tools to measure quality of life and physical function, while also investigating the immunologic mechanisms involved in these changes. The long-term goal is to enhance treatment outcomes for metastatic cancer patients through the integration of exercise therapy.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with metastatic prostate cancer receiving their first palliative course of radiation therapy.
Not a fit: Patients who are already engaging in more than 90 minutes of exercise therapy per week or have contraindications for exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and survival rates for patients with metastatic prostate cancer undergoing radiation therapy.
How similar studies have performed: Other studies have shown promising results with exercise therapy in cancer treatment, suggesting potential benefits, although this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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 * Primary attending radiation oncologist approval Exclusion Criteria: * 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)
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Nicholas Zaorsky, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
- Study coordinator: Nicholas G Zaorsky, MD, MS
- Email: Nicholas.Zaorsky@uhhospitals.org
- Phone: 1-800-641-2422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.