TrialPath
← Back to searchRecruiting

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

NCT07463092 · University of Sao Paulo
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy
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.
Eligibility criteria
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 design
Enrollment target: 34 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-05-01
Estimated completion: 2029-01
Last updated: 2026-04-08
Interventions
Dietary Supplement: Creatine MonohydrateDietary Supplement: MaltodextrinBehavioral: Resistance training
Primary outcomes
  • Muscle Density (Ultrasound-derived Echo Intensity and Thickness) (Baseline and 12 weeks.)
Sponsor
University of Sao Paulo · other
With: InCor Heart Institute, Medical school of the University of São Paulo (FMUSP), Instituto do Cancer do Estado de São Paulo
Contacts & investigators
ContactGuilherme WP da Fonseca, PhD · contact · guilhermefonseca@usp.br · +55 11 3091 2137
ContactComitê de Ética em Pesquisa da EEFE-USP · contact · cep39@usp.br · +55 11 3091 3097
InvestigatorGuilherme WP da Fonseca, PhD · principal_investigator, School of Physical Education and Sport - USP
All locations (1)
School of Physical Education and Sport - USPRecruiting
São Paulo, São Paulo, Brazil