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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04556045
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Nicholas G Zaorsky, MD, MS
Phone 1-800-641-2422
Status Recruiting
Phase N/A
Start date December 11, 2023
Completion date January 1, 2026

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