Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in total lean mass (kg) as measured by whole-body dual energy x-ray absorptiometry (DXA) scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm
研究概览
简要总结
The goal of this clinical trial is to test the use of creatine monohydrate supplementation with resistance training to preserve muscle mass and help lessen prostate cancer progression.
The main question it aims to answer is if this treatment will help maintain muscle mass to help in reducing fatigue and improving physical function, independence, and quality of life.
Participants will be asked to participate in a 52-week exercise intervention consisting of a twice weekly telehealth resistance training program.
详细描述
This is a parallel, double-blind randomized controlled trial to test the effects of 52-weeks of creatine monohydrate supplementation with resistance training (Cr+RT) compared with placebo (PLA) and RT (PLA+RT) with our team's established, effective, home-based, telehealth RT program in 200 metastatic castration sensitive prostate cancer (mCSPC) survivors receiving androgen deprivation therapy (ADT). The study team will evaluate muscle mass, health outcomes (fatigue, physical function, independence, insulin sensitivity, quality of life), and markers or cancer progression (prostate specific antigen, cell-free DNA) at baseline, mid-point, and 52-weeks. RT will be carried out twice weekly with elastic resistance bands, and the study will utilize an established creatine monohydrate supplementation protocol for creatine and PLA delivery.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The participants, the investigators, and all members of the study team will be blinded to the treatment assignment.
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
- •Subject age ≥ 18 years old.
- •Metastatic castration-sensitive prostate cancer patients who have not met criteria for disease progression (per Prostate Cancer Working Group guidelines) on current systemic therapy
- •Currently treated with surgical castration or medical castration with Gonadotropin-releasing hormone (GnRH) agonists/antagonists, and/or an androgen receptor pathway inhibitor (ARPI)) aka novel hormone therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). Must have started the current regimen at least 12 weeks prior to enrollment.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- •Not currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training (e.g., time set aside in your day to workout) ≥ two days per week.
- •Regular access to an electronic device with internet service and ability for video calls (e.g., 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.
- •Willingness to engage in a home-based resistance exercise program two days per week.
- •Willingness to take creatine monohydrate supplementation or placebo for the duration of the 52 week trial and to avoid taking additional creatine-containing supplementation or other nutritional supplementation during the study period.
- •Willingness to complete and submit weekly supplementation logs to study personnel throughout the duration of the 52-week study via email, text, in person, or verbally verified over the phone.
- •Willingness to complete three in-person assessment sessions (baseline, 24-, and 52-weeks).
- •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/1.73m
- •ECOG Performance Status ≥ 3
研究组 & 干预措施
Arm 1
Home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr)
干预措施: Home-based, telehealth (Behavioral)
Arm 2
Home-based, telehealth resistance training (RT) with placebo (PLA)
干预措施: Placebo (Other)
Arm 2
Home-based, telehealth resistance training (RT) with placebo (PLA)
干预措施: Home-based, telehealth (Behavioral)
Arm 1
Home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr)
干预措施: creatine monohydrate (Dietary Supplement)
结局指标
主要结局
Change in total lean mass (kg) as measured by whole-body dual energy x-ray absorptiometry (DXA) scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm
时间窗: 52 weeks
To test the efficacy of 52-weeks of home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) or placebo (PLA), Cr+RT vs. PLA+RT, on changes in muscle mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
次要结局
未报告次要终点