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

Official title

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

Overview

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 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.

Primary outcome measures

• Muscle Density (Ultrasound-derived Echo Intensity and Thickness) [Time frame: Baseline and 12 weeks.]

Secondary outcome measures (2)

• Muscle strength [Time frame: Baseline and 12 weeks.]
• Muscle mass [Time frame: Baseline and 12 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• School of Physical Education and Sport - USP — São Paulo

Publications

• Yuan F, Wang Y, Xiao X, Zhang X, Jing M, Kamecki H, Tan YG, Barreras SG, Aragon-Ching JB, Ma Z, Zhang P, Chang D, You Y. A systematic review evaluating the effectiveness of exercise training on physical condition in prostate cancer patients undergoing androgen deprivation therapy. Transl Androl Urol. 2023 Aug 31;12(8):1336-1350. doi: 10.21037/tau-23-272. Epub 2023 Aug 4. PMID 37680229
• McTiernan A, Friedenreich CM, Katzmarzyk PT, Powell KE, Macko R, Buchner D, Pescatello LS, Bloodgood B, Tennant B, Vaux-Bjerke A, George SM, Troiano RP, Piercy KL; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity in Cancer Prevention and Survival: A Systematic Review. Med Sci Sports Exerc. 2019 Jun;51(6):1252-1261. doi: 10.1249/MSS.0000000000001937. PMID 31095082
• Kovac MB, Pavlin T, Cavka L, Ribnikar D, Spazzapan S, Templeton AJ, Seruga B. The trajectory of sarcopenia following diagnosis of prostate cancer: A systematic review and meta-analysis. J Geriatr Oncol. 2023 Sep;14(7):101594. doi: 10.1016/j.jgo.2023.101594. Epub 2023 Jul 22. PMID 37482497

Identifiers

NCT: NCT07463092 · 89367125.1.3001.0068

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗