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

NCT06112990 | Recruiting Phase 3 DMC

• 2 other identifiers: HCI1681251R01CA281759-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in total lean mass (kg) as measured by whole-body dual energy x-ray absorptiometry (DXA) scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm

  To test the efficacy of 52-weeks of home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) or placebo (PLA), Cr+RT vs. PLA+RT, on changes in muscle mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).

  52 weeks

Other Outcomes (9)

• Change in fatigue score as measured by the FACIT-Fatigue questionnaire from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.

  52 weeks

• Change in physical function scores as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.

  52 weeks

• Change in physical function scores as measured by the Short Physical Performance Battery test from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.

  52 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr)

Dietary Supplement: creatine monohydrate; Behavioral: Home-based, telehealth

Arm 2

PLACEBO COMPARATOR

Home-based, telehealth resistance training (RT) with placebo (PLA)

Other: Placebo; Behavioral: Home-based, telehealth

Interventions

creatine monohydrate DIETARY_SUPPLEMENT

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.

Also known as: Creatine

Arm 1

Placebo OTHER

Placebo supplementation consists of a flavorless, colorless, dextrose powder and will be supplied in concealed, unlabeled packaging.

Arm 2

Home-based, telehealth BEHAVIORAL

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 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
• Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2.
• ECOG Performance Status ≥ 3

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (1)

• Coletta AM, Simon LH, Maslana K, Taylor S, Larson K, Hansen PA, Thomas VM, Ulrich CM, Kohli M, Chipman J, Swami U, Gupta S, Maughan BL, Agarwal N. Creatine supplementation and resistance training to preserve muscle mass and attenuate cancer progression (CREATINE-52): a protocol for a double-blind randomized controlled trial. BMC Cancer. 2024 Apr 18;24(1):493. doi: 10.1186/s12885-024-12260-3.

  PMID: 38637770 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Creatine; Telemedicine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Adriana Coletta, PhD, MS, RD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Sharry

CONTACT

801-585-3453; susan.sharry@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participants, the investigators, and all members of the study team will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized, controlled trial

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 2, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)