Actively Recruiting

Phase Not Applicable
Age: 40Years +
MALE
NCT07463092

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

Led by University of Sao Paulo · Updated on 2026-04-08

34

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo

Lead Sponsor

I

InCor Heart Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 60; 40 years
  • Histologically or cytologically confirmed localized prostate cancer
  • Underwent surgical or pharmacological castration with GnRH/LHRH agonists or antagonists for at least six months before intervention
  • Receiving continuous or intermittent androgen deprivation therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 64; 2
  • Not engaged in resistance training in the three months before intervention
  • Not using creatine supplementation in the three months before intervention
  • Willing to participate in 12-week resistance training three times per week and daily supplementation with creatine or maltodextrin
Not Eligible

You will not qualify if you...

  • Insulin-dependent diabetes mellitus
  • Dialysis-dependent renal failure
  • Severe chronic liver disease
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m�b2
  • Receiving hormonal treatment not established by the medical team
  • Planning to undergo chemotherapy within the next six months

AI-Screening

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Trial Site Locations

Total: 1 location

1

School of Physical Education and Sport - USP

São Paulo, São Paulo, Brazil, 05508-030

Actively Recruiting

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Research Team

G

Guilherme WP da Fonseca, PhD

CONTACT

C

Comitê de Ética em Pesquisa da EEFE-USP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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