This trial studies how well resistance training with or without creatine monohydrate supplement works in improving body composition and health outcomes in patients with prostate cancer that has spread to other places in the body (metastatic). Resistance training, with or without creatine monohydrate supplement, may help to improve feelings of tiredness and overall physical function in patients with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03987217.
PRIMARY OBJECTIVE:
I. To evaluate the change in lean mass with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
SECONDARY OBJECTIVES:
I. To evaluate change in other body composition variables (i.e. fat mass, fat-free mass, percent body fat, appendicular lean mass) with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
II. To evaluate the change in health outcomes associated with body composition (i.e. physical function, fatigue, insulin regulation) with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
III. To examine associations between creatine supplementation use and changes in biomarkers linked with prostate cancer progression (prostate specific antigen [PSA] and markers of the immune system and allostatic load).
IV. To evaluate the degree of adherence to the creatine supplementation protocol.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients complete Personal Optimism with Exercise Recovery (POWER) resistance training program sessions twice weekly over 30-60 minute each for 12 weeks. Patients undergo dual X-ray absorptiometry (DXA) scans on the trial as well as blood sample collection during screening and on the trial.
GROUP II: Patients complete POWER resistance training program sessions twice weekly over 30-60 minutes each for 12 weeks and receive creatine monohydrate supplementation orally (PO) 4 times daily during week 1, and then once daily (QD) during weeks 2-12. Patients undergo DXA scans on the trial as well as blood sample collection during screening and on the trial.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorAdriana Coletta