Resistance Exercise and Creatine in Colorectal Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Resistance Exercise

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, it's 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 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 who are sarcopenic. 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 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, 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." 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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ciaran Fairman; Phone Number: 803-576-8397; Email: cfairman@mailbox.sc.edu
• Study Contact Backup: Name: Alex Brooks; Email: amb91@email.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Recruiting
      • University of South Carolina
      • Contact: Ciaran Fairman; Phone Number: 803-576-8397; Email: cfairman@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. are receiving active treatment for their cancer;
2. have a any contraindication to exercise participation;
3. have been participating in structured resistance exercise 2 or more times per week for the past 6 months;
4. are currently taking supplements containing creatine for 4 weeks prior to the start of the RCT, or
5. are receiving medications that might alter body composition (metformin, corticosteroids etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise + Creatine; 3 days a week of resistance exercise for 10-weeks + 5g day of creatine monohydrate supplementation	Behavioral: Resistance Exercise; Supervised resistance exercise
Placebo Comparator: Exercise + Placebo; 3 days a week of resistance exercise for 10-weeks + 5g day of placebo (dextrose supplementation	Behavioral: Resistance Exercise; Supervised resistance exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Number of individuals enrolled across study timeframe	10-weeks
Retention	Proportion of individuals who return for follow-up testing	10-weeks
Supplementation Adherence	Proportion of daily supplementation taken	10-weeks
Exercise Adherence	Proportion of total exercise achieved	10-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular Strength	Leg Press and Chest press 5 repetition maximum	0 and 10-weeks
Handgrip Strength	Handgrip Dynamometry (Jamar Plus+)	0 and 10-weeks
Body Composition	DEXA	0 and 10-weeeks
Physical Function	Short Physical Performance Battery	0 and 10-weeks
Health-Related Quality of Life	European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30).	0 and 10-weeks
Sarcopenia related quality of life	Sarcopenia-related HRQOL will be assessed using a sarcopenia-specific questionnaire (SarQoL).	0 and 10-weeks
Inflammatory Markers	C reative protein, Interleukin 6 and Tumor necrosis factor alpha	0 and 10-weeks
Intramuscular Signaling and Mitochondrial Health and skeletal muscle regulation	Intramuscular markers of mitochondrial content and biogenesis (complex I-V content, citrate synthase activity, and PGC-1a protein expression)	0 and 10-weeks

Collaborators and Investigators

• Sponsor: University of South Carolina
• Investigators: Principal Investigator: Ciaran Fairman, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): July 22, 2025
• Study Completion (Estimated): July 22, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Pro00127362

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No