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

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.

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

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

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Surgical resection of primary tumour improves aerobic performance in colorectal cancer. [2014]

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]

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]

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]

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]

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]

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

Safety of creatine supplementation. [2019]

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

Resistance Exercise Counteracts Tumor Growth in Two Carcinoma Rodent Models. [2020]