Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420726
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-14
Brief Title:
Resistance Exercise and Creatine in Colorectal Cancer
Sponsor:
University of South Carolina
Organization:
University of South Carolina
Study Overview
Official Title:
The Feasibility and Acceptability of Resistance Training and Creatine Supplementation to Promote Physical Function in Sarcopenic Colorectal Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 sarcopenia 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 sarcopenic colorectal cancer survivors 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
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 sarcopenic colorectal cancer survivors 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
Detailed Description:
Colorectal cancer is the third most commonly diagnosed cancer in the world Sarcopenia defined as a loss of skeletal muscle mass and function is highly prevalent in colorectal cancer with rates of up to 60 reported Sarcopenia etiology in cancer is multifactorial with aging and inactivity compounded by treatment toxicities malnutrition tumor burden and high-grade inflammation Consequently its unlikely that unimodal interventions will be sufficient to overcome the burden of sarcopenia in this population Creatine monohydrate is a naturally occurring compound in the body that plays a critical role in energy provision during exercise4 Creatine is the most widely studied nutritional supplement to date with well over 1000 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 who are sarcopenic We propose a randomized controlled pilot trial examining the effects of 10-week multimodal resistance exercise and creatine supplementation EXSUPP n20 relative to resistance exercise alone EXPLA n20 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 colorectal cancer patients diagnosed with sarcopenia after cancer treatment 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 ie 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 Treatments Debilitating Side Effects Our trial is innovative in addressing one of the most important health problems for individuals treated for colorectal cancer in that it will be the first to 1 examine the feasibility and acceptability of a multimodal exercise and nutritional intervention relative to exercise alone in individuals treated for colorectal cancer who are sarcopenic and 2 explore the molecular mechanisms underpinning the response to exercise and nutritional interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None