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

Launched by UNIVERSITY OF UTAH · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at whether taking creatine supplements along with a resistance training program can help men with metastatic prostate cancer preserve their muscle mass and slow down the progression of their cancer. The researchers want to find out if this combination can reduce fatigue and improve physical function, independence, and overall quality of life for participants.

To be eligible for this trial, participants must be male adults aged 18 or older, currently receiving treatment for metastatic prostate cancer, and not currently doing regular resistance training. Participants will need to commit to a year-long program that includes a telehealth resistance training session twice a week and taking either creatine or a placebo (a non-active substance) during the study. They will also need to complete some assessments at the beginning, halfway through, and at the end of the trial. Importantly, participants should have access to a device for video calls and be willing to keep track of their supplement intake throughout the study.

Gender

MALE

Eligibility criteria

• 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.
• • 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.
• 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