Actively Recruiting
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
Eligibility Criteria
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
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
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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