RecruitingPhase 3NCT06112990

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial


Sponsor

University of Utah

Enrollment

200 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test the use of creatine monohydrate supplementation with resistance training to preserve muscle mass and help lessen prostate cancer progression. The main question it aims to answer is if this treatment will help maintain muscle mass to help in reducing fatigue and improving physical function, independence, and quality of life. Participants will be asked to participate in a 52-week exercise intervention consisting of a twice weekly telehealth resistance training program.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether creatine supplements combined with a home exercise program can help men with advanced prostate cancer maintain muscle mass and slow disease progression. Participants will follow a resistance training program twice a week and take either creatine or a placebo for one year. **You may be eligible if:** - You are 18 or older - You have metastatic prostate cancer (spread to other parts of the body) that hasn't progressed on your current hormone therapy - You are currently on hormone therapy (such as abiraterone, enzalutamide, or similar drugs) for at least 12 weeks - You are NOT already doing structured resistance exercise at least twice a week - You have access to the internet and a device for video calls - You have a MyChart account or are willing to create one **You may NOT be eligible if:** - You received chemotherapy in the last 12 weeks - You have poor kidney function (eGFR below 30) - You are in very poor overall health (ECOG 3 or higher) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTcreatine monohydrate

Creatine is part of the phosphagen system and plays a critical role in energy metabolism. Creatine monohydrate supplementation increases availability of creatine and phosphocreatine in the skeletal muscle. Increased phosphocreatine enables greater buffering of adenosine triphosphate, an organic compound providing energy to cells, enhancing training volume (e.g., an individual can work-out harder and longer).This augmentation in exercise capacity amplifies training adaptations. Additionally, creatine monohydrate supplementation reduces levels of inflammatory markers, which are associated with severe muscle loss.

OTHERPlacebo

Placebo supplementation consists of a flavorless, colorless, dextrose powder and will be supplied in concealed, unlabeled packaging.

BEHAVIORALHome-based, telehealth

Home-based, individualized, whole-body RT program, supervised via the telehealth platform within the electronic medical record system. The RT program consists of 12 resistance exercises, focusing on all major muscle groups including upper and lower body, core, and whole-body. Exercises within each participant's individualized RT program progress with a periodization model as recommended by the American College of Sports Medicine. In addition, the cancer exercise trainer will inquire about space availability in the home for completing resistance prior to developing the personalized prescription. This logistical information is key to ensure feasibility of completing the exercises prescribed. Participants will be provided with beginner and advanced sets of elastic resistance bands to enable progression throughout the 52-week study.


Locations(1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

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NCT06112990


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