Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

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
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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, appendicu...

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 inflammatory markers). 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.

Tracking Information

NCT #
NCT03987217
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Adriana Coletta Huntsman Cancer Institute/ University of Utah