Resistance Exercise + Creatine for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Ciaran Fairman, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of South Carolina

Must not be taking: Metformin, Corticosteroids

Disqualifiers: Active cancer treatment, Exercise contraindication, others

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Resistance Exercise + Creatine for Colorectal Cancer?

Research suggests that resistance training can help increase muscle mass and strength, which is beneficial for cancer patients experiencing muscle loss. Additionally, creatine has been shown to improve muscle strength and may help with weight loss issues in cancer patients. ^{1 2 3 4 5}

Is resistance exercise and creatine supplementation safe for humans?

Resistance exercise and creatine supplementation are generally well-tolerated in most people, including those with cancer. Short-term studies show no significant side effects, but there are isolated reports of issues with muscles, kidneys, and digestion. Long-term safety data is limited. ^{2 4 5 6 7}

How is the treatment of resistance exercise and creatine unique for colorectal cancer?

This treatment is unique because it combines resistance exercise, which helps increase muscle strength and mass, with creatine supplementation, known to enhance physical performance. Unlike standard treatments like chemotherapy, this approach focuses on improving physical fitness and potentially counteracting muscle loss and fatigue associated with cancer treatments. ^{2 3 5 6 8}

Research Team

Ciaran Fairman, PhD

Principal Investigator

University of South Carolina

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Resistance Exercise (Other)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of South Carolina Columbia, SC

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Patients Recruited

122,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Surgical resection of primary tumour improves aerobic performance in colorectal cancer. [2014] Colorectal cancer is the third most common cancer in the UK, with patients suffering declines in muscle mass and aerobic function. We hypothesised that tumour removal in non-metastatic colorectal cancer would lead to a restoration of lean muscle mass and increases in objective and subjective measures of aerobic performance.

2. United States 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. [2019] Neoadjuvant chemoradiation treatment (CRT) in rectal cancer patients is associated with a reduction in physical capacity, lean mass and increased fatigue. As a countermeasure to these treatment-related adverse effects, we examined the feasibility and preliminary efficacy of a 10-week exercise program during CRT.

3. England 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. [2023] The standard treatment pathway for locally advanced rectal cancer is neoadjuvant chemoradiotherapy (CRT) followed by surgery. Neoadjuvant CRT has been shown to decrease physical fitness, and this decrease is associated with increased post-operative morbidity. Exercise training can stimulate skeletal muscle adaptations such as increased mitochondrial content and improved oxygen uptake capacity, both of which are contributors to physical fitness. The aims of the EMPOWER trial are to assess the effects of neoadjuvant CRT and an in-hospital exercise training programme on physical fitness, health-related quality of life (HRQoL), and physical activity levels, as well as post-operative morbidity and cancer staging.

4. England 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. [2022] Multiple pilot studies, including one in colorectal cancer patients, suggest that creatine, an amino acid derivative, augments muscle, improves strength, and thereby could palliate the cancer anorexia/weight loss syndrome.

5. United States pubmed.ncbi.nlm.nih.gov

Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study): Protocol for a Randomized Controlled Trial. [2023] Creatine supplementation is an effective ergogenic nutrient for athletes, as well as for people starting a health or fitness program. Resistance training has previously been identified as an important method of increasing muscle mass and strength, especially in people with cancer to avoid sarcopenia. The potential of creatine supplementation for adaptations produced by resistance training in patients with cancer is still unknown. The primary aim of this study is to evaluate the effectiveness of a supervised resistance training program intervention with and without creatine supplementation in patients with breast cancer.

6. England 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. [2020] Creatine supplementation has consistently been demonstrated to augment adaptations in body composition, muscle strength and physical function in a variety of apparently healthy older adults and clinical populations. The effects of creatine supplementation and resistance training in individuals with cancer have yet to be investigated. This study aims to examine the effects of creatine supplementation in conjunction with resistance training on body composition, muscle strength and physical function in prostate cancer patients undergoing androgen deprivation therapy.

7. United States pubmed.ncbi.nlm.nih.gov

Safety of creatine supplementation. [2019] The literature on creatine supplementation supporting its efficacy has grown rapidly and has included studies in both healthy volunteers and patient populations. However, the first rule in the development of therapeutic agents is safety. Creatine is well-tolerated in most individuals in short-term studies. However, isolated reports suggest creatine may be associated with various side effects affecting several organ systems including skeletal muscle, the kidney and the gastrointestinal tract. The majority of clinical studies fail to find an increased incidence of side effects with creatine supplementation. To date, studies have not found clinically significant deviations from normal values in renal, hepatic, cardiac or muscle function. Few data are available on the long-term consequences of creatine supplementation.

8. United States pubmed.ncbi.nlm.nih.gov

Resistance Exercise Counteracts Tumor Growth in Two Carcinoma Rodent Models. [2020] Although resistance exercise (RE) is now recognized as an adjuvant in cancer treatment because of its capacity to prevent muscle wasting, weakness, and cachexia, it is unknown whether RE can mitigate tumor development. Two solid adenocarcinoma models (Walker-256 and Ehrlich) were used to investigate the effects of RE on tumor cell proliferation, growth, and aggressiveness parameters in tumor-bearing animals' life span.