Trial Title:
Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression
NCT ID:
NCT06112990
Condition:
Metastatic Prostate Cancer
Conditions: Official terms:
Disease Progression
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Double-blind, placebo-controlled, randomized, controlled trial
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
The participants, the investigators, and all members of the study team will be blinded to
the treatment assignment.
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
creatine monohydrate
Description:
Creatine is part of the phosphagen system and plays a critical role in energy metabolism.
Creatine monohydrate supplementation increases availability of creatine and
phosphocreatine in the skeletal muscle. Increased phosphocreatine enables greater
buffering of adenosine triphosphate, an organic compound providing energy to cells,
enhancing training volume (e.g., an individual can work-out harder and longer).This
augmentation in exercise capacity amplifies training adaptations. Additionally, creatine
monohydrate supplementation reduces levels of inflammatory markers, which are associated
with severe muscle loss.
Arm group label:
Arm 1
Other name:
Creatine
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo supplementation consists of a flavorless, colorless, dextrose powder and will be
supplied in concealed, unlabeled packaging.
Arm group label:
Arm 2
Intervention type:
Behavioral
Intervention name:
Home-based, telehealth
Description:
Home-based, individualized, whole-body RT program, supervised via the telehealth platform
within the electronic medical record system. The RT program consists of 12 resistance
exercises, focusing on all major muscle groups including upper and lower body, core, and
whole-body. Exercises within each participant's individualized RT program progress with a
periodization model as recommended by the American College of Sports Medicine. In
addition, the cancer exercise trainer will inquire about space availability in the home
for completing resistance prior to developing the personalized prescription. This
logistical information is key to ensure feasibility of completing the exercises
prescribed. Participants will be provided with beginner and advanced sets of elastic
resistance bands to enable progression throughout the 52-week study.
Arm group label:
Arm 1
Arm group label:
Arm 2
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.
Detailed 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.
Criteria for 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
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adriana Coletta, PHD, MS, RD
Phone:
801-213-6012
Email:
adriana.coletta@hci.utah.edu
Start date:
November 9, 2023
Completion date:
November 30, 2028
Lead sponsor:
Agency:
University of Utah
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Utah
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06112990
