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临床试验/NCT06420726
NCT06420726已完成不适用

The Feasibility and Acceptability of Resistance Training and Creatine Supplementation to Promote Physical Function in Sarcopenic Colorectal Cancer Survivors

University of South Carolina1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Retention

研究概览

简要总结

Low skeletal muscle mass and function, is prevalent in up to 60% of colorectal cancer patients. This condition arises from a combination of factors such as aging, inactivity, treatment side effects, malnutrition, tumor burden, and inflammation. Given this complexity, singular interventions may not be sufficient to address low muscle mass in this group.

Creatine monohydrate, a compound vital for energy during exercise, has been extensively researched and proven safe and effective across various demographics, including older adults and clinical populations. Studies show that creatine enhances benefits from resistance training, indicating potential to counter muscle mass and function decline post-cancer treatment.

This study aims to assess the feasibilty of combining creatine supplementation with resistance training versus resistance training alone in colorectal cancer survivors treated with chemotherapy. A randomized controlled pilot trial will compare a 10-week program of resistance exercise plus creatine (EXSUPP) with resistance exercise alone (EXPLA), each with 20 participants.

详细描述

Colorectal cancer is the third most commonly diagnosed cancer in the world. Low muscle mass etiology in cancer is multifactorial, with aging and inactivity compounded by treatment toxicities, malnutrition, tumor burden, and high-grade inflammation. Consequently, it's unlikely that unimodal interventions will be sufficient to overcome the burden of low muscle mass in this population. Creatine monohydrate is a naturally occurring compound in the body that plays a critical role in energy provision during exercise.4 Creatine is the most widely studied nutritional supplement to date, with well over 1,000 studies establishing its safety and effectiveness in men, women and older adults, in addition to other clinical populations. There is strong and consistent evidence that creatine supplementation can enhance the positive adaptations to resistance training in older adults and clinical populations. Therefore, there is strong potential for the application of creatine and resistance training to offset the decline in muscle mass and function after cancer treatment. The purpose of the proposed study is to examine the feasibility and acceptability of creatine supplementation combined with resistance exercise, compared to resistance exercise alone in individuals treated for colorectal cancer. We propose a randomized controlled pilot trial, examining the effects of 10-week multimodal resistance exercise and creatine supplementation (EXSUPP) (n=20) relative to resistance exercise alone (EXPLA) (n=20) in individuals treated for colorectal cancer who have sarcopenia. The specific aims of this project are to 1) determine the feasibility and acceptability of the intervention in individuals with colorectal cancer 2) compare the effects of an exercise and creatine supplementation intervention (EXSUPP) to exercise alone (EXPLA) on body composition, muscle strength, physical function, and quality of life and 3) explore muscle molecular-level adaptations, i.e., mitochondrial health and protein turnover, in response to the interventions. This project will be one of the first to combine exercise with creatine, specifically targeting sarcopenia in individuals previously treated for colorectal cancer. This project is directly in line with the priority research initiative from the NCI Cancer MoonshotSM to "minimize Cancer Treatment's Debilitating Side Effects."

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals ≥12 months post treatment with chemotherapy for colorectal cancer
  • •>18 years

排除标准

  • •are receiving active treatment for their cancer;
  • •had a musculoskeletal, cardiovascular, neurological, or psychological condition that precluded participation in RET;
  • •had been participating in structured RET two or more times per week for the past 6 months
  • •are currently taking supplements containing creatine for 4 weeks prior to the start of the RCT, or
  • •are receiving medications that might alter body composition (metformin, corticosteroids etc.).

研究组 & 干预措施

Exercise + Creatine

Experimental

3 days a week of resistance exercise for 10-weeks + 5g day of creatine monohydrate supplementation

干预措施: Resistance Exercise (Behavioral)

Exercise + Placebo

Placebo Comparator

3 days a week of resistance exercise for 10-weeks + 5g day of placebo (dextrose supplementation

干预措施: Resistance Exercise (Behavioral)

结局指标

主要结局

Retention

时间窗: 10-weeks

Proportion of individuals who return for follow-up testing

Recruitment

时间窗: 10-weeks

Number of individuals enrolled across study timeframe

Supplementation Adherence

时间窗: 10-weeks

Proportion of daily supplementation taken

Exercise Adherence

时间窗: 10-weeks

Proportion of total exercise achieved

次要结局

  • Muscular Strength(0 and 10-weeks)
  • Sarcopenia related quality of life(0 and 10-weeks)
  • Intramuscular Signaling and Mitochondrial Health and skeletal muscle regulation(0 and 10-weeks)
  • Handgrip Strength(0 and 10-weeks)
  • Physical Function(0 and 10-weeks)
  • Inflammatory Markers(0 and 10-weeks)
  • Health-Related Quality of Life(0 and 10-weeks)
  • Body Composition(0 and 10-weeeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciaran Fairman

Assistant Professor

University of South Carolina

研究点 (1)

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