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NCT Number: NCT07463092

Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer 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.

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

Participants will receive 5 g/day of creatine monohydrate throughout the 12-week supervised resistance training program.

Maltodextrin

Dietary Supplement

Participants will receive 5 g/day of maltodextrin, matched in appearance and caloric content to creatine, throughout the 12-week supervised resistance training program.

Resistance training

Behavioral

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, Supervised resistance training, Progressive resistance training

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Muscle mass

    Time frame: Baseline and 12 weeks.

    Muscle mass will be assessed using Dual-energy X-ray absorptiometry (DXA).

Study contacts

Contact information is provided by the study sponsor or research team.

Comitê de Ética em Pesquisa da EEFE-USP

CONTACT

[email protected]

+55 11 3091 3097

Guilherme WP da Fonseca, PhD

CONTACT

[email protected]

+55 11 3091 2137

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 10, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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