RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial

Quick Facts

Study Start:2023-11-09

Study Completion:2028-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06112990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Susan Sharry

CONTACT

801-585-3453

susan.sharry@hci.utah.edu

Principal Investigator

Adriana Coletta, PhD, MS, RD

PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Study Locations (Sites)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Adriana Coletta, PhD, MS, RD, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute/ University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-09

Study Completion Date2028-11-30

Study Record Updates

Study Start Date2023-11-09

Study Completion Date2028-11-30

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Prostate Cancer