NCT03987217已完成早期 1 期
Creatine Supplementation With Resistance Training: A Novel Approach to Improving Body Composition and Associated Health Outcomes Among Prostate Cancer Patients
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Change in lean mass
研究概览
简要总结
This trial studies how well resistance training with or without creatine monohydrate supplement works in improving body composition and health outcomes in patients with prostate cancer that has spread to other places in the body. Resistance training, with or without creatine monohydrate supplement, may help to improve feelings of tiredness and overall physical function in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the change in lean mass with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
SECONDARY OBJECTIVES:
I. To evaluate change in other body composition variables (i.e. fat mass, fat-free mass, percent body fat, appendicular lean mass) with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
II. To evaluate the change in health outcomes associated with body composition (i.e. physical function, fatigue, insulin regulation) with 12 weeks of creatine supplementation + resistance training compared to resistance training alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Metastatic prostate cancer patients who have not met criteria for disease progression on ongoing systemic therapy.
- •Currently treated with CYP17A1 inhibitors, surgical castration or medical castration with GnRH (gonadotropin-releasing hormone) agonists/antagonists, or androgen receptor blockers. Must have started the current regimen at least 12 weeks prior to enrollment.
- •Confirmation by the patient's treating oncologist that the patient is able to start the exercise program.
- •Regular access to an electronic device with internet service and ability for video calls (i.e. computer, smart phone, ipad, tablet, etc).
- •Access to an active MyChart account or the willingness to create an account for the purposes of the trial.
- •Must be able to read and understand English.
- •Willingness to engage in a home-based resistance exercise program two days per week.
- •If randomized to the creatine + resistance training group, willingness to take creatine monohydrate supplementation for the duration of the 12 week trial and avoid taking additional creatine-containing supplementation or other supplementation during the study period.
- •If randomized to the resistance training group without creatine supplementation, willingness to avoid taking creatine monohydrate supplementation or additional creatine-containing supplementation or other supplementation during the study period.
- •For participants randomized to the creatine arm willingness to complete and submit Weekly Creatine Supplementation logs to study personnel via email, fax, or in person.
- •Willingness to complete two assessment sessions (baseline and end-of-study).
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m^
- •Metastatic disease that, in the opinion of the treating oncologist, may obstruct compliant participation in the exercise program (i.e. extensive bone disease).
- •Current or planned treatment with radiation therapy. *Subjects who may later require radiation therapy for their health and wellbeing during the course of the trial may be allowed to continue on trial, pending consultation with the PI, treating oncologist, and medical monitor (and DSMC as applicable).
结局指标
主要结局
Change in lean mass
时间窗: Baseline to 12 weeks post intervention
Assessed by whole-body dual x-ray absorptiometry (DXA) scan.
次要结局
- Change in fat mass(Baseline to 12 weeks post intervention)
- Change in fat-free mass(Baseline to 12 weeks post intervention)
- Change in percent body fat(Baseline to 12 weeks post intervention)
- Change in appendicular lean mass(Baseline to 12 weeks post intervention)
- Change in physical function(Baseline to 12 weeks post intervention)
- Change in fatigue(Baseline to 12 weeks post intervention)
- Change in insulin regulation(Baseline to 12 weeks post intervention)
- Change in serum PSA (prostate specific antigen) markers of the immune system and allostatic load(Baseline to 12 weeks post intervention)
- Plasma markers of allostatic load: Interleukin-6 (IL-6)(Baseline to 12 weeks post intervention)
- Plasma markers of allostatic load: Insulin(Baseline to 12 weeks post intervention)
- Plasma markers of allostatic load: Glucose(Baseline to 12 weeks post intervention)
- Total percent of creatine supplementation consumed at end of study(Baseline up to 12 weeks post intervention)
- Plasma markers of the immune system(Baseline up to 12 weeks post intervention)
研究者
研究点 (2)
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