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

NCT07463092 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-08

No results posted yet for this study

Summary

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

Interventions

DIETARY_SUPPLEMENT

Creatine Monohydrate

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

DIETARY_SUPPLEMENT

Maltodextrin

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

BEHAVIORAL

Resistance training

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.

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER

  • Medical school of the University of São Paulo (FMUSP)

    collaborator UNKNOWN

  • Instituto do Cancer do Estado de São Paulo

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Guilherme WP da Fonseca, PhD · School of Physical Education and Sport - USP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463092 on ClinicalTrials.gov