NCT03987217

Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

Creatine Supplementation With Resistance Training: A Novel Approach to Improving Body Composition and Associated Health Outcomes Among Prostate Cancer Patients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Resistance training, with or without creatine monohydrate supplement, may help to improve feelings of tiredness and overall physical function in patients with prostate cancer.

Detailed description

PRIMARY OBJECTIVES: 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. 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.

Conditions

• Fatigue
• Metastatic Prostate Carcinoma
• Sedentary Lifestyle
• Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8
• Stage IVA Prostate Cancer AJCC (American Joint Committee on Cancer) v8
• Stage IVB Prostate Cancer AJCC (American Joint Committee on Cancer) v8

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Creatine Monohydrate	Given orally
BEHAVIORAL	Exercise Intervention	Complete POWER resistance training program
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-06-17
• Primary completion: 2025-03-10
• Completion: 2025-03-10
• First posted: 2019-06-14
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States