Resistance Exercise and Creatine in Colorectal Cancer

NCT06420726 | Recruiting

• 1 other identifier: Pro00127362
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• Recruitment

  Number of individuals enrolled across study timeframe

  10-weeks

• Retention

  Proportion of individuals who return for follow-up testing

  10-weeks

• Supplementation Adherence

  Proportion of daily supplementation taken

  10-weeks

• Exercise Adherence

  Proportion of total exercise achieved

  10-weeks

Secondary Outcomes (8)

• Muscular Strength

  0 and 10-weeks

• Handgrip Strength

  0 and 10-weeks

• Body Composition

  0 and 10-weeeks

• Physical Function

  0 and 10-weeks

• Health-Related Quality of Life

  0 and 10-weeks

Study Arms (2)

Exercise + Creatine

EXPERIMENTAL

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

Behavioral: Resistance Exercise

Exercise + Placebo

PLACEBO COMPARATOR

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

Behavioral: Resistance Exercise

Interventions

Resistance Exercise BEHAVIORAL

Supervised resistance exercise

Exercise + Creatine; Exercise + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• are receiving active treatment for their cancer;
• have a any contraindication to exercise participation;
• have been participating in structured resistance exercise 2 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.).

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29201, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ciaran Fairman, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ciaran Fairman

CONTACT

803-576-8397; cfairman@mailbox.sc.edu

Alex Brooks

CONTACT

amb91@email.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-arm Randomized Controlled Trial

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: January 9, 2024
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (1)