Fatigue Clinical Trial - Resistance Training +/- Creatine for Metastatic

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Fatigue
Metastatic Prostate Carcinoma
Prostatic Neoplasms
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

Clinical Trial Details

NCT number	NCT03987217
Study type	Interventional
Source	University of Utah
Contact	Susan Sharry
Phone	801-585-3453
Email	susan.sharry@hci.utah.edu
Status	Recruiting
Phase	Early Phase 1
Start date	June 17, 2019
Completion date	June 7, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Resistance Training +/- Creatine for Metastatic Prostate Cancer Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms