Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06112990

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

Led by University of Utah · Updated on 2025-04-16

200

Participants Needed

1

Research Sites

264 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Metastatic castration-sensitive prostate cancer patients without disease progression on current systemic therapy
  • Currently treated with surgical or medical castration and/or androgen receptor pathway inhibitor started at least 12 weeks before enrollment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Not currently doing structured resistance training two or more days per week
  • Regular access to an electronic device with internet and video call ability
  • Access to or willingness to create an active MyChart account for the trial
  • Willing to participate in home-based resistance exercise twice weekly
  • Willing to take creatine monohydrate or placebo supplementation for 52 weeks and avoid other creatine or nutritional supplements during the study
  • Willing to complete and submit weekly supplementation logs throughout the 52 weeks
  • Willing to attend three in-person assessments at baseline, 24 weeks, and 52 weeks
  • Able to provide informed consent and willing to sign the approved consent form
Not Eligible

You will not qualify if you...

  • Received cytotoxic chemotherapy within 12 weeks before enrollment
  • Estimated Glomerular Filtration Rate (eGFR) below 30 ml/min/1.73m2
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or higher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

S

Susan Sharry

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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