Using creatine and resistance training to help maintain muscle mass in prostate cancer patients
Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial
This study tests whether taking creatine and doing resistance training can help men with prostate cancer keep their muscle mass and feel better over a year.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06112990 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of creatine monohydrate supplementation combined with a telehealth resistance training program over 52 weeks for patients with metastatic castration-sensitive prostate cancer. The study aims to determine if this intervention can preserve muscle mass, reduce fatigue, and improve overall physical function and quality of life. Participants will be randomly assigned to receive either the creatine supplementation with resistance training or a placebo with resistance training, with evaluations conducted at baseline, mid-point, and after 52 weeks. The trial will also assess markers of cancer progression throughout the study.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with metastatic castration-sensitive prostate cancer who are currently undergoing androgen deprivation therapy.
Not a fit: Patients who are already adhering to national physical activity guidelines for resistance training or those with disease progression may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help prostate cancer patients maintain muscle mass and improve their quality of life during treatment.
How similar studies have performed: Other studies have shown promising results with similar interventions combining exercise and nutritional supplementation in cancer care, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Adriana Coletta, PhD, MS, RD — Huntsman Cancer Institute/ University of Utah
- Study coordinator: Susan Sharry
- Email: susan.sharry@hci.utah.edu
- Phone: 801-585-3453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.