## Protocol Section
### Identification Module
**NCT ID:** NCT06420726

**Brief Title:** Resistance Exercise and Creatine in Colorectal Cancer

**Official Title:** The Feasibility and Acceptability of Resistance Training and Creatine Supplementation to Promote Physical Function in Sarcopenic Colorectal Cancer Survivors

#### Organization Study ID Info
**ID:** Pro00127362
#### Organization
**Class:** OTHER
**Full Name:** University of South Carolina
### Status Module
#### Completion Date
**Date:** 2025-07-22

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-07-22

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of South Carolina

#### Responsible Party

**Investigator Affiliation:** University of South Carolina

**Investigator Full Name:** Ciaran Fairman

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Colorectal cancer is the third most commonly diagnosed cancer in the world. Sarcopenia, defined as a loss of skeletal muscle mass and function, is highly prevalent in colorectal cancer, with rates of up to 60% reported. Sarcopenia 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 sarcopenia 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 who are sarcopenic. 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 colorectal cancer patients? diagnosed with sarcopenia after cancer treatment, 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." Our trial is innovative in addressing one of the most important health problems for individuals treated for colorectal cancer in that it will be the first to 1) examine the feasibility and acceptability of a multimodal exercise and nutritional intervention relative to exercise alone in individuals treated for colorectal cancer who are sarcopenic and 2) explore the molecular mechanisms underpinning the response to exercise and nutritional interventions.

### Conditions Module

**Conditions:**

- Colorectal Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Two-arm Randomized Controlled Trial

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Resistance Exercise

**Label:** Exercise + Creatine

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Resistance Exercise

**Label:** Exercise + Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exercise + Creatine

- Exercise + Placebo

**Description:** Supervised resistance exercise

**Name:** Resistance Exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Number of individuals enrolled across study timeframe

**Measure:** Recruitment

**Time Frame:** 10-weeks

**Description:** Proportion of individuals who return for follow-up testing

**Measure:** Retention

**Time Frame:** 10-weeks

**Description:** Proportion of daily supplementation taken

**Measure:** Supplementation Adherence

**Time Frame:** 10-weeks

**Description:** Proportion of total exercise achieved

**Measure:** Exercise Adherence

**Time Frame:** 10-weeks

#### Secondary Outcomes

**Description:** Leg Press and Chest press 5 repetition maximum

**Measure:** Muscular Strength

**Time Frame:** 0 and 10-weeks

**Description:** Handgrip Dynamometry (Jamar Plus+)

**Measure:** Handgrip Strength

**Time Frame:** 0 and 10-weeks

**Description:** DEXA

**Measure:** Body Composition

**Time Frame:** 0 and 10-weeeks

**Description:** Short Physical Performance Battery

**Measure:** Physical Function

**Time Frame:** 0 and 10-weeks

**Description:** European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30).

**Measure:** Health-Related Quality of Life

**Time Frame:** 0 and 10-weeks

**Description:** Sarcopenia-related HRQOL will be assessed using a sarcopenia-specific questionnaire (SarQoL).

**Measure:** Sarcopenia related quality of life

**Time Frame:** 0 and 10-weeks

**Description:** C reative protein, Interleukin 6 and Tumor necrosis factor alpha

**Measure:** Inflammatory Markers

**Time Frame:** 0 and 10-weeks

**Description:** Intramuscular markers of mitochondrial content and biogenesis (complex I-V content, citrate synthase activity, and PGC-1a protein expression)

**Measure:** Intramuscular Signaling and Mitochondrial Health and skeletal muscle regulation

**Time Frame:** 0 and 10-weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

1. are receiving active treatment for their cancer;
2. have a any contraindication to exercise participation;
3. have been participating in structured resistance exercise 2 or more times per week for the past 6 months;
4. are currently taking supplements containing creatine for 4 weeks prior to the start of the RCT, or
5. are receiving medications that might alter body composition (metformin, corticosteroids etc.).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cfairman@mailbox.sc.edu

**Name:** Ciaran Fairman

**Phone:** 803-576-8397

**Role:** CONTACT

**Contact 2:**

**Email:** amb91@email.sc.edu

**Name:** Alex Brooks

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Columbia

**Contacts:**

***Contact 1:***

- **Email:** cfairman@mailbox.sc.edu

- **Name:** Ciaran Fairman

- **Phone:** 803-576-8397

- **Role:** CONTACT

**Country:** United States

**Facility:** University of South Carolina

**State:** South Carolina

**Status:** RECRUITING

**Zip:** 29201

#### Overall Officials

**Official 1:**

**Affiliation:** University of South Carolina

**Name:** Ciaran Fairman, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T385

- Name: Creatine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
