Resistance Exercise and Creatine in Colorectal Cancer

June 3, 2026 updated by: Ciaran Fairman, University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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."

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. are receiving active treatment for their cancer;
  2. had a musculoskeletal, cardiovascular, neurological, or psychological condition that precluded participation in RET;
  3. had been participating in structured RET two 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

September 15, 2025

Study Completion (Actual)

September 15, 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)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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