Colorectal CancerNCT06420726
Resistance Exercise and Creatine in Colorectal Cancer
A study testing Resistance Exercise in people with Colorectal Cancer, run by University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals ≥12 months post treatment with chemotherapy for colorectal cancer
- >18 years
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29201
About this study
Official title: 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.
Read the 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."
- Conditions
- Colorectal Cancer
- Being tested
- Resistance Exercise
- Keywords
- Resistance exercise, strength training
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
Supervised resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise + Creatine | Experimental | 3 days a week of resistance exercise for 10-weeks + 5g day of creatine monohydrate supplementation Receives: Behavioral: Resistance Exercise |
| Exercise + Placebo | Placebo comparator | 3 days a week of resistance exercise for 10-weeks + 5g day of placebo (dextrose supplementation Receives: Behavioral: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of individuals enrolled across study timeframe
Measured: 10-weeks
Retention
Proportion of individuals who return for follow-up testing
Measured: 10-weeks
Supplementation Adherence
Proportion of daily supplementation taken
Measured: 10-weeks
Exercise Adherence
Proportion of total exercise achieved
Measured: 10-weeks
Secondary outcomes (8)
Muscular Strength
Leg Extension and Chest press 1 repetition maximum
Measured: 0 and 10-weeks
Handgrip Strength
Handgrip Dynamometry (Jamar Plus+)
Measured: 0 and 10-weeks
Body Composition
DEXA
Measured: 0 and 10-weeeks
Physical Function
Short Physical Performance Battery
Measured: 0 and 10-weeks
Health-Related Quality of Life
European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30).
Measured: 0 and 10-weeks
Sarcopenia related quality of life
Sarcopenia-related HRQOL will be assessed using a sarcopenia-specific questionnaire (SarQoL).
Measured: 0 and 10-weeks
Inflammatory Markers
C reative protein, Interleukin 6 and Tumor necrosis factor alpha
Measured: 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)
Measured: 0 and 10-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Sep 2023
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciaran Fairman, University of South Carolina
- Investigators
- Ciaran Fairman, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420726
- Sponsor's protocol ID
- Pro00127362
- Status last verified
- Jun 2026
- First submitted
- 14 May 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fairman CM, Brooks AM, Candow DG, Jackson KE, Bottone G, Scott B, Anderson KS, Hirsch KR, Cardaci TD, VanderVeen BN, Blake CE, Zhang T, Zhang J, Murphy EA. Examining the feasibility and preliminary effects of resistance exercise training and creatine supplementation in individuals treated for colorectal cancer. PLoS One. 2026 Jul 15;21(7):e0353630. doi: 10.1371/journal.pone.0353630. eCollection 2026.
PubMed 42455839
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of Resistance Training and Creatine Supplementation to Promote Physical Function in Sarcopenic Colorectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT06420726
- Acronym / sponsor ID
- Pro00127362
- Conditions
- Colorectal Cancer
- Keywords
- Resistance exercise, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Exercise + Creatine | Experimental | Behavioral: Resistance Exercise3 days a week of resistance exercise for 10-weeks + 5g day of creatine monohydrate supplementation |
| Exercise + Placebo | Placebo comparator | Behavioral: Resistance Exercise3 days a week of resistance exercise for 10-weeks + 5g day of placebo (dextrose supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals ≥12 months post treatment with chemotherapy for colorectal cancer
- >18 years
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseSupervised resistance exercise | Behavioural | Exercise + Creatine, Exercise + Placebo |
Primary outcome
Recruitment
Time frame: 10-weeks
Number of individuals enrolled across study timeframe
Retention
Time frame: 10-weeks
Proportion of individuals who return for follow-up testing
Supplementation Adherence
Time frame: 10-weeks
Proportion of daily supplementation taken
Exercise Adherence
Time frame: 10-weeks
Proportion of total exercise achieved
8 secondary outcomes
Muscular Strength
Time frame: 0 and 10-weeks
Handgrip Strength
Time frame: 0 and 10-weeks
Body Composition
Time frame: 0 and 10-weeeks
Physical Function
Time frame: 0 and 10-weeks
Health-Related Quality of Life
Time frame: 0 and 10-weeks
Sarcopenia related quality of life
Time frame: 0 and 10-weeks
Inflammatory Markers
Time frame: 0 and 10-weeks
Intramuscular Signaling and Mitochondrial Health and skeletal muscle regulation
Time frame: 0 and 10-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 42455839Fairman CM, Brooks AM, Candow DG, Jackson KE, Bottone G, Scott B, Anderson KS, Hirsch KR, Cardaci TD, VanderVeen BN, Blake CE, Zhang T, Zhang J, Murphy EA. Examining the feasibility and preliminary effects of resistance exercise training and creatine supplementation in individuals treated for colorectal cancer. PLoS One. 2026 Jul 15;21(7):e0353630. doi: 10.1371/journal.pone.0353630. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciaran Fairman, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with Colorectal Cancer, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 10-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06420726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.