Resistance Exercise + Creatine for Colorectal Cancer

Overseen By Ciaran Fairman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Metformin, Corticosteroids

Disqualifiers: Active cancer treatment, Exercise contraindication, others

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how combining resistance exercise (also known as resistance training or strength training) with creatine supplements can improve muscle mass and function in colorectal cancer survivors. Many survivors experience muscle loss due to aging and cancer treatments, and this study tests whether adding creatine to exercise offers better results than exercise alone. Participants will follow a 10-week program with either creatine or a placebo while performing resistance exercises three times a week. The trial seeks colorectal cancer survivors who completed treatment at least a year ago, are not currently exercising heavily, and are not taking creatine or certain medications. As an unphased trial, it offers survivors the chance to contribute to innovative research that could enhance recovery and quality of life.

Will I have to stop taking my current medications?

The trial requires that participants not be on medications that might alter body composition, such as metformin or corticosteroids. If you are taking these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that creatine monohydrate is safe and effective for many individuals, including older adults and those with various health conditions. Studies indicate that it can enhance the benefits of strength training, aiding in the prevention of muscle loss and improving muscle function after cancer treatment.

Exercising after a colorectal cancer diagnosis is generally safe and unlikely to cause issues. This suggests that combining creatine with strength exercises should be well-tolerated.

Although this trial is preliminary, the widespread use and safety record of creatine offer some confidence in its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for colorectal cancer focus on chemotherapy, radiation, or surgery. However, researchers are excited about the combination of resistance exercise and creatine supplementation because it introduces a non-invasive approach that could complement these standard treatments. This treatment harnesses the power of regular physical activity, which is known to improve muscle mass and strength, and pairs it with creatine, a supplement that might enhance energy production in cells. This method could potentially improve patients' quality of life and physical resilience during cancer treatment, offering a fresh angle in supportive care for colorectal cancer.

What evidence suggests that this trial's treatments could be effective for sarcopenia in colorectal cancer survivors?

Research has shown that combining creatine with strength exercises can increase muscle mass and function, especially in colorectal cancer survivors. In this trial, one group of participants will receive resistance exercise combined with creatine supplementation. Creatine, a substance that provides energy during workouts, has been found to enhance the benefits of strength training. Studies indicate that creatine can help prevent the loss of muscle mass and function that may occur after cancer treatments. This combination aims to combat sarcopenia, the loss of muscle, by providing more energy and improving exercise outcomes. Overall, using creatine with resistance training might more effectively maintain muscle health in these patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Ciaran Fairman, PhD

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for colorectal cancer survivors who have sarcopenia, a condition involving loss of muscle mass and function. Participants should be interested in a 10-week program that includes resistance exercise with or without creatine supplementation.

Inclusion Criteria

I finished my colorectal cancer treatment over a year ago.

I am older than 18 years.

Exclusion Criteria

Individuals with any contraindication to exercise participation

Individuals who have been participating in structured resistance exercise 2 or more times per week for the past 6 months

I am currently undergoing treatment for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week program of resistance exercise with either creatine supplementation or placebo

10 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistance Exercise

Trial Overview The study compares two groups: one doing resistance exercises while taking creatine (EXSUPP) and the other doing just the exercises (EXPLA). The goal is to see if adding creatine improves muscle health after cancer treatment.

How Is the Trial Designed?

Group I: Exercise + Creatine Experimental Treatment 1 Intervention

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

Group II: Exercise + Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Published Research Related to This Trial

Resistance exercise (RE) significantly reduced tumor growth and improved tumor characteristics in two adenocarcinoma models (Walker-256 and Ehrlich), as evidenced by lower histological grades and decreased tumor cell proliferation after 4 weeks of exercise.

RE also increased tumor microvessel density in Walker-256 tumor-bearing rats, suggesting enhanced vascularization, although it did not extend the lifespan of the animals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Counteracts Tumor Growth in Two Carcinoma Rodent Models. Padilha, CS., Testa, MT., Marinello, PC., et al.[2020]

This study is a randomized, double-blind, placebo-controlled trial investigating the effects of creatine supplementation combined with resistance training on body composition and physical function in prostate cancer patients undergoing androgen deprivation therapy, with a focus on fat-free mass as the primary endpoint.

If successful, the trial could show that creatine supplementation enhances the benefits of resistance training, potentially improving body composition and quality of life for cancer patients, which would be significant for future treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: a randomised, double-blind, placebo-controlled trial. Fairman, CM., Kendall, KL., Newton, RU., et al.[2020]

This study aims to evaluate the effectiveness of a 16-week supervised resistance training program, with and without creatine supplementation, in patients with breast cancer, focusing on improving muscle strength and preventing sarcopenia.

Participants will be randomly assigned to either a resistance training group or a resistance training plus creatine group, allowing researchers to assess the specific impact of creatine on strength adaptations in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study): Protocol for a Randomized Controlled Trial. Martinez Aguirre-Betolaza, A., Cacicedo, J., Castañeda-Babarro, A.[2023]

A 10-week exercise program during neoadjuvant chemoradiation treatment for rectal cancer was feasible and well tolerated by 10 patients, leading to significant improvements in leg strength and endurance despite some loss in muscle mass.

The exercise intervention helped enhance physical performance, as evidenced by improved walking speed and balance, while showing minimal impact on quality of life and fatigue, suggesting potential benefits in maintaining physical function during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Efficacy of a 10-Week Resistance and Aerobic Exercise Intervention During Neoadjuvant Chemoradiation Treatment in Rectal Cancer Patients. Singh, F., Galvão, DA., Newton, RU., et al.[2019]

The EMPOWER trial is a randomized controlled study involving 46 patients with locally advanced rectal cancer, aiming to assess the impact of an in-hospital exercise training program on physical fitness and post-operative outcomes after neoadjuvant chemoradiotherapy (CRT).

The primary focus is on measuring improvements in oxygen uptake at lactate threshold, with secondary outcomes including health-related quality of life and post-operative morbidity, which could provide insights into how exercise may enhance recovery and overall health in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial. Loughney, L., West, MA., Kemp, GJ., et al.[2023]

Creatine supplementation is generally well-tolerated in most individuals during short-term studies, with no significant increase in side effects reported in the majority of clinical trials.

While isolated reports suggest potential side effects affecting organs like the kidneys and gastrointestinal tract, studies have not shown clinically significant changes in renal, hepatic, cardiac, or muscle function, and data on long-term effects are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of creatine supplementation. Persky, AM., Rawson, ES.[2019]

In patients with non-metastatic colorectal cancer, tumor removal significantly improved their anaerobic threshold, indicating better aerobic performance post-surgery, although their lean muscle mass remained unchanged.

Self-reported physical activity levels decreased after tumor resection, suggesting that objective measures like cardiopulmonary exercise testing are more reliable for assessing recovery and performance capability than subjective reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical resection of primary tumour improves aerobic performance in colorectal cancer. Williams, JP., Nyasavajjala, SM., Phillips, BE., et al.[2014]

In a randomized trial involving 263 patients with cancer-related weight loss, creatine supplementation did not lead to significant weight gain or improvements in appetite, quality of life, or muscle strength compared to a placebo.

The study found no differences in adverse events or survival rates between the creatine and placebo groups, indicating that creatine, as used in this trial, was ineffective for managing cancer anorexia/weight loss syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled randomized trial of creatine for the cancer anorexia/weight loss syndrome (N02C4): an Alliance trial. Jatoi, A., Steen, PD., Atherton, PJ., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06420726/resistance-exercise-and-creatine-in-colorectal-cancer

Resistance Exercise and Creatine in Colorectal Cancer Studies show that creatine enhances benefits from resistance training, indicating potential to counter muscle mass and function decline post- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11025211/

Creatine supplementation and resistance training to ... Creatine supplementation and resistance training to preserve muscle mass and attenuate cancer progression (CREATINE-52): a protocol for a double-blind ...

3. withpower.com withpower.com/trial/phase-colorectal-neoplasms-8-2023-800ea

Resistance Exercise + Creatine for Colorectal Cancer Studies show that creatine enhances benefits from resistance training, indicating potential to counter muscle mass and function decline post-cancer treatment.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39124745/

Effects of a Resistance Exercise Program in Patients with ... This study aims to evaluate the efficacy of a strength exercise program in reducing CIPN in patients with colorectal cancer undergoing chemotherapy.

5. ascopost.com ascopost.com/news/october-2025/creatine/

Creatine Of note, preclinical findings suggest that creatine may have a direct impact on cancer: It suppressed tumor growth14 but also promoted ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06420726

Resistance Exercise and Creatine in Colorectal Cancer This study aims to assess the feasibilty of combining creatine supplementation with resistance training versus resistance training alone in sarcopenic ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/487375

Resistance Exercise and Creatine in Colorectal Cancer Studies show that creatine enhances benefits from resistance training, indicating potential to counter muscle mass and function decline post-cancer treatment.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7513291/

Exercise and colorectal cancer: a systematic review ... The present findings suggest that exercise following colorectal cancer diagnosis is associated with a low risk of adverse event, is feasible, ...