About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Creatine Monohydrate
- Maltodextrin
- Resistance training
Treatment groups
Sponsors and collaborators
University of Sao Paulo
Lead sponsor
InCor Heart Institute
Collaborator
Medical school of the University of São Paulo (FMUSP)
Collaborator
Instituto do Cancer do Estado de São Paulo
Collaborator