NCT06112990

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a parallel, double-blind randomized controlled trial to test the effects of 52-weeks of creatine monohydrate supplementation with resistance training (Cr+RT) compared with placebo (PLA) and RT (PLA+RT) with our team's established, effective, home-based, telehealth RT program in 200 metastatic castration sensitive prostate cancer (mCSPC) survivors receiving androgen deprivation therapy (ADT). We will evaluate muscle mass, health outcomes (fatigue, physical function, independence, insulin sensitivity, quality of life), and markers or cancer progression (prostate specific antigen, cell-free DNA) at baseline, mid-point, and 52-weeks. RT will be carried out twice weekly with elastic resistance bands, and we will utilize an established creatine monohydrate supplementation protocol for creatine and PLA delivery.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	creatine 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.
OTHER	Placebo	Placebo supplementation consists of a flavorless, colorless, dextrose powder and will be supplied in concealed, unlabeled packaging.
BEHAVIORAL	Home-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.

Timeline

• Start date: 2023-11-09
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2023-11-02
• Last updated: 2025-04-16

Locations

1 site across 1 country: United States