Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy

April 7, 2026 updated by: Guilherme Wesley Peixoto da Fonseca, University of Sao Paulo

The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy

This randomized, double-blind, placebo-controlled clinical trial will investigate the effects of creatine supplementation combined with a 12-week supervised resistance training program on muscle mass, muscle strength, physical performance (e.g., parameters of sarcopenia), and muscle density in men with prostate cancer undergoing androgen deprivation therapy (ADT). ADT often causes loss of lean mass, reduced muscle strength, functional impairment, and increased fat mass. Eligible male patients will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) in a double-blind manner, in addition to participating in the resistance exercise program. Assessments will be performed at baseline and after the 12-week intervention period and will include:

  • Muscle density and architecture assessed by ultrasound
  • Body composition (lean mass and fat mass)
  • Muscle strength
  • Physical performance (functional performance tests)
  • Inflammatory biomarkers
  • Vascular function parameters

The primary goal is to assess whether creatine supplementation combined with resistance training can safely improve muscle quality and quantity, strength, and physical function in these patients. If effective and safe, the intervention could help reduce muscle loss and improve quality of life in men undergoing ADT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Men receiving androgen-deprivation therapy (ADT) for prostate cancer often experience significant loss of muscle mass, reduction in muscle strength, and increased fat mass. These changes can lead to sarcopenia, poorer physical function, and lower quality of life. Resistance training is known to improve muscle mass and strength in this population, but it is not clear whether adding creatine supplementation can further enhance these benefits. This study will investigate whether combining creatine monohydrate supplementation with a 12-week supervised resistance training program leads to greater improvements in muscle health compared to resistance training alone. Creatine is a nutritional supplement that may help increase muscle energy availability and support muscle growth and function, but its effects in men undergoing ADT have not been fully established. Participants will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) once daily throughout the 12-week resistance training program. All patients will follow the same structured resistance exercise protocol, supervised by trained professionals. The study will evaluate changes in muscle mass, muscle strength, physical performance, muscle density measured by ultrasound, inflammatory markers, vascular function, and other indicators of muscle health. The goal of this study is to determine whether creatine supplementation is a safe and effective strategy to improve muscle quality, physical function, and overall health for men receiving ADT. Findings from this trial may help guide future recommendations for exercise and nutritional support in this population.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Comitê de Ética em Pesquisa da EEFE-USP
  • Phone Number: +55 11 3091 3097
  • Email: cep39@usp.br

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05508-030
        • Recruiting
        • School of Physical Education and Sport - USP
        • Contact:
        • Contact:
          • Comitê de Ética em Pesquisa da EEFE-USP
          • Phone Number: +55 11 3091 3097
          • Email: cep39@usp.br
        • Principal Investigator:
          • Guilherme WP da Fonseca, PhD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men aged ≥ 40 years;
  • Patients with histologically or cytologically confirmed localized prostate cancer;
  • Patients who have undergone surgical castration or pharmacological castration with gonadotropin-releasing hormone (GnRH/LHRH) agonists or antagonists for at least six months prior to the start of the intervention;
  • Patients receiving continuous or intermittent androgen deprivation therapy;
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  • Not engaged in resistance training in the three months prior to the intervention;
  • Not using creatine supplementation in the three months prior to the intervention;
  • Willing to participate in a 12-week intervention consisting of resistance training performed three times per week and daily supplementation with creatine monohydrate or maltodextrin.

Exclusion Criteria:

  • Patients with insulin-dependent diabetes mellitus;
  • Patients with dialysis-dependent renal failure;
  • Patients with severe chronic liver disease;
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²;
  • Any hormonal treatment outside that established by the medical team;
  • Patients planning to undergo chemotherapy within the next six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Creatine Supplementation + Resistance Training
Participants assigned to the experimental arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of creatine monohydrate. Creatine supplementation will be administered daily throughout the intervention period.
Dietary supplement: Creatine Monohydrate
Participants will receive 5 g/day of creatine monohydrate throughout the 12-week supervised resistance training program.
Behavioral: Resistance training
Participants will complete a 12-week supervised, progressive resistance training program designed to improve muscle strength and muscle mass. Training sessions will be conducted under professional supervision and will occur three times per week. The program will target major muscle groups of the upper and lower body using weight machines and free weights. All participants in both study arms will follow the same resistance training protocol.
Other Names:
  • Strength training
  • Progressive resistance training
  • Supervised resistance training
Active Comparator: Placebo (Maltodextrin) + Resistance Training
Participants assigned to the control arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of maltodextrin. Maltodextrin will be administered daily throughout the intervention period.
Behavioral: Resistance training
Participants will complete a 12-week supervised, progressive resistance training program designed to improve muscle strength and muscle mass. Training sessions will be conducted under professional supervision and will occur three times per week. The program will target major muscle groups of the upper and lower body using weight machines and free weights. All participants in both study arms will follow the same resistance training protocol.
Other Names:
  • Strength training
  • Progressive resistance training
  • Supervised resistance training
Dietary supplement: Maltodextrin
Participants will receive 5 g/day of maltodextrin, matched in appearance and caloric content to creatine, throughout the 12-week supervised resistance training program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Density (Ultrasound-derived Echo Intensity and Thickness)
Time Frame: Baseline and 12 weeks.
Muscle density will be assessed using ultrasound-derived measurements, including muscle thickness and echo intensity of selected muscle groups. Higher muscle density reflects improved muscle quality.
Baseline and 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Baseline and 12 weeks.
Muscle strength will be assessed using a handgrip dynamometer. The higher value of three attempts will be used.
Baseline and 12 weeks.
Muscle mass
Time Frame: Baseline and 12 weeks.
Muscle mass will be assessed using Dual-energy X-ray absorptiometry (DXA).
Baseline and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

InCor Heart Institute
Instituto do Cancer do Estado de São Paulo
Medical school of the University of São Paulo (FMUSP)

Investigators

  • Principal Investigator: Guilherme WP da Fonseca, PhD, School of Physical Education and Sport - USP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89367125.1.3001.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Decision has not been made yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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