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

Last updated: April 2, 2024
Sponsor: University of Utah
Overall Status: Active - Recruiting

Phase

3

Condition

Metastatic Cancer

Prostate Cancer, Early, Recurrent

Prostate Cancer

Treatment

Home-based, telehealth

creatine monohydrate

Placebo

Clinical Study ID

NCT06112990
HCI168125
1R01CA281759-01
10066516
  • Ages > 18
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Subject age ≥ 18 years old.
  • Metastatic castration-sensitive prostate cancer patients who have not met criteria fordisease progression (per Prostate Cancer Working Group guidelines) on current systemictherapy
  • Currently treated with surgical castration or medical castration withGonadotropin-releasing hormone (GnRH) agonists/antagonists, and/or an androgenreceptor pathway inhibitor (ARPI)) aka novel hormone therapy (e.g., abiraterone,enzalutamide, apalutamide, darolutamide). Must have started the current regimen atleast 12 weeks prior to enrollment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • Not currently adhering to national physical activity guidelines for resistancetraining, as defined as participating in structured resistance training (e.g., timeset aside in your day to workout) ≥ two days per week.
  • Regular access to an electronic device with internet service and ability for videocalls (e.g., computer, smart phone, iPad, tablet, etc).
  • Access to an active MyChart account or the willingness to create an account for thepurposes 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 durationof the 52 week trial and to avoid taking additional creatine-containingsupplementation or other nutritional supplementation during the study period.
  • Willingness to complete and submit weekly supplementation logs to study personnelthroughout the duration of the 52-week study via email, text, in person, or verballyverified 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 thatconforms to federal and institutional guidelines.

Exclusion

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

Study Design

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: Home-based, telehealth
Phase: 3
Study Start date:
November 09, 2023
Estimated Completion Date:
November 30, 2028

Study 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, 24-, 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.

Connect with a study center

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

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