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Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06112990•University of Utah

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Subject age ≥ 18 years old.
•Metastatic castration-sensitive prostate cancer patients who have not met criteria for disease progression (per Prostate Cancer Working Group guidelines) on current systemic therapy
•Currently treated with surgical castration or medical castration with Gonadotropin-releasing hormone (GnRH) agonists/antagonists, and/or an androgen receptor pathway inhibitor (ARPI)) aka novel hormone therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). Must have started the current regimen at least 12 weeks prior to enrollment.
•Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
•Not currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training (e.g., time set aside in your day to workout) ≥ two days per week.
•Regular access to an electronic device with internet service and ability for video calls (e.g., computer, smart phone, iPad, tablet, etc).
•Access to an active MyChart account or the willingness to create an account for the purposes of the trial.
•Willingness to engage in a home-based resistance exercise program two days per week.
•Willingness to take creatine monohydrate supplementation or placebo for the duration of the 52 week trial and to avoid taking additional creatine-containing supplementation or other nutritional supplementation during the study period.
•Willingness to complete and submit weekly supplementation logs to study personnel throughout the duration of the 52-week study via email, text, in person, or verbally verified over the phone.
+2 more criteria

Exclusion Criteria

•Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
•Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2.
•ECOG Performance Status ≥ 3

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

November 9, 2023

Primary Completion Date

November 30, 2028

Completion Date

November 30, 2028

Last Updated

April 16, 2025

Enrollment

200

ESTIMATED participants

Conditions

Metastatic Prostate Cancer

Interventions

creatine monohydrate

DIETARY_SUPPLEMENT

Placebo

OTHER

Home-based, telehealth

BEHAVIORAL

Contacts

Susan Sharry

CONTACT

801-585-3453 susan.sharry@hci.utah.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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