Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer
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ClinicalTrials.gov Identifier: NCT04556045 |
Recruitment Status :
Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : November 26, 2021
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Tracking Information | |||||||||
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First Submitted Date ICMJE | July 28, 2020 | ||||||||
First Posted Date ICMJE | September 21, 2020 | ||||||||
Last Update Posted Date | November 26, 2021 | ||||||||
Estimated Study Start Date ICMJE | February 1, 2022 | ||||||||
Estimated Primary Completion Date | February 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS Scale v1.2-Global Health) [ Time Frame: At 1 month follow up ] Patient Reported Outcome Measurement Information System (PROMIS) Global Health v1. 2 short form is a 10-item instrument representing multiple domains. Scores are assigned for both Global Physical Health component and Global Mental Health component. The response scores range from 1-5, where 1 = always and 5 = Never. A higher score from responses indicate better health.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer | ||||||||
Official Title ICMJE | Exercise Therapy and Radiation Therapy (EXERT) for Metastatic Prostate Cancer | ||||||||
Brief Summary | Exercise therapy has been shown to improve quality of life for cancer patients receiving chemotherapy. The combination of exercise therapy + radiation therapy for men with prostate cancer receiving radiation has never been studied. In the current work of exercise therapy + radiation therapy (EXERT) for metastatic prostate cancer, we will assess how patient quality of life changes after treatment (Aim 1). We believe that exercise will reduce the side effects of the radiation and therefore improve quality of life. Additionally, we believe that the mechanism behind the improvement is due to changes to the immune system, so we will measure changes in immune function (Aim 2). Since quality of life predicts survival, and exercise therapy may improve quality of life, we believe that exercise therapy for these men will improve their length of life (Aim 3). | ||||||||
Detailed 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. Aim 1. Quantify the potential of ET to mitigate RT toxicities and physical function decline. The hypothesis is that ET mitigates patient-reported QOL and toxicities of RT. Our approach in 1A will be to use standardized questionnaires and assessment tools: toxicity is measured using the NIH Patient-Reported Outcomes Measurement Information System library + Common Terminology Criteria for Adverse Events. In 1B, we will use 30-second chair stand and timed up-and-go. Pre vs post difference scores for each variable would be compared with a generalized estimating equations (GEE) model with an ordinal logistic link function. Aim 2. Characterize the immunologic mechanism by which ET mitigates RT toxicity. The hypothesis is that ET training mitigates toxicity of RT (measured in aim 1) by increasing serum interleukin-1Ra. Our approach will be to measure IL-1Ra pre-RT and 1 month post-RT±ET. We will similarly measure exploratory pro-inflammatory (IL-1B, IL-6, TNF-α, IL-8, IL-15, CRP) and anti-inflammatory (IL-10) markers using a GEE model with ordinal logistic link function. Aim 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 random assignment to date of death. This pilot work is essential for the development of a full scale randomized trial, to be funded by an R01 application to NCI, planned for submission within 1 year of pilot study completion. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Metastatic Prostate Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
80 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | February 1, 2025 | ||||||||
Estimated Primary Completion Date | February 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04556045 | ||||||||
Other Study ID Numbers ICMJE | STUDY00015277 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Nicholas Zaorsky, Case Comprehensive Cancer Center | ||||||||
Original Responsible Party | Nicholas Zaorsky, Milton S. Hershey Medical Center, Assistant Professor, Department of Radiation Oncology | ||||||||
Current Study Sponsor ICMJE | Milton S. Hershey Medical Center | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Milton S. Hershey Medical Center | ||||||||
Verification Date | November 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |