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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Willingness to complete three in-person assessment sessions (baseline, 24-, and 52-weeks).

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Locations
United States
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Contact Information
Primary
Susan Sharry
susan.sharry@hci.utah.edu
801-585-3453
Time Frame
Start Date: 2023-11-09
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 200
Treatments
Experimental: Arm 1
Home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr)
Placebo_comparator: Arm 2
Home-based, telehealth resistance training (RT) with placebo (PLA)
Related Therapeutic Areas
Sponsors
Leads: University of Utah
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov