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

The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07463092
Enrollment
34
Registered
2026-03-10
Start date
2026-05-01
Completion date
2029-01-01
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Sarcopenia

Keywords

Prostate Cancer, Androgen Deprivation Therapy, Creatine, Resistance Training, Muscle Density, Sarcopenia

Brief 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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTCreatine Monohydrate

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

DIETARY_SUPPLEMENTMaltodextrin

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

BEHAVIORALResistance 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

University of Sao Paulo
Lead SponsorOTHER
InCor Heart Institute
CollaboratorOTHER
Medical school of the University of São Paulo (FMUSP)
CollaboratorUNKNOWN
Instituto do Cancer do Estado de São Paulo
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Both participants and investigators are blinded to group assignment, managed by an external researcher. The supplements are identical in appearance, taste, and caloric content.

Intervention model description

Two-group parallel assignment comparing creatine supplementation with resistance training versus placebo with resistance training for 12 weeks.

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle Density (Ultrasound-derived Echo Intensity and Thickness)Baseline and 12 weeks.Muscle density will be assessed using ultrasound-derived measurements, including muscle thickness and echo intensity of selected muscle groups. Higher muscle density reflects improved muscle quality.

Secondary

MeasureTime frameDescription
Muscle strengthBaseline and 12 weeks.Muscle strength will be assessed using a handgrip dynamometer. The higher value of three attempts will be used.
Muscle massBaseline and 12 weeks.Muscle mass will be assessed using Dual-energy X-ray absorptiometry (DXA).

Countries

Brazil

Contacts

CONTACTGuilherme WP da Fonseca, PhD
guilhermefonseca@usp.br+55 11 3091 2137
CONTACTComitê de Ética em Pesquisa da EEFE-USP
cep39@usp.br+55 11 3091 3097
PRINCIPAL_INVESTIGATORGuilherme WP da Fonseca, PhD

School of Physical Education and Sport - USP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026