Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression (CREATINE-52)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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, mid-point, 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Susan Sharry
Data sourced from clinicaltrials.gov
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