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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether creatine monohydrate, a supplement, plus strength training can help keep muscle and slow prostate cancer growth. It is for adults whose prostate cancer has spread but still responds to hormone treatment. The study lasts 52 weeks, with strength training by video call twice a week, and will look at tiredness, physical ability, independence, and quality of life.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older and have prostate cancer that has spread, still responds to hormone treatment, and has not worsened on your current treatment.
- You receive treatment that lowers or blocks male hormones, through surgery or medicine. Your current treatment must have started at least 12 weeks before joining.
- You can care for yourself and are up and about for more than half of your waking hours, even if you cannot work.
- You do not already do planned strength training two or more days a week.
- You have regular access to an internet device for video calls and have a MyChart account or will create one.
- You will do home strength training twice a week and take creatine or a placebo (a look-alike with no creatine) for 52 weeks. You will avoid extra creatine and other nutrition supplements.
- You will report supplement use each week and attend three in-person visits: at the start, at 24 weeks, and at 52 weeks.
- You can understand and agree to join the study and will sign a consent form.
Who can't join
- You received cell-killing chemotherapy within 12 weeks before joining.
- Your kidney filtering test result, called eGFR, is below 30.
- You need help with daily self-care and spend more than half of your waking hours in bed or a chair, or are more limited.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
UT
- Huntsman Cancer Institute · Salt Lake City, UT 84112Adriana Coletta, PHD, MS, RD · Study contact · 801-213-6012 · adriana.coletta@hci.utah.eduMore trials in Salt Lake City