Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients

NCT06780423 | Recruiting

• 1 other identifier: 2021/148 - CTLm-CCP
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Until now, cancer is still associated with high morbidity and mortality, and is therefore a big issue for the public health. Colorectal cancer is the second leading cause of cancer death in developed countries. In advanced colorectal cancer, 60% of these patients develop cachexia. The presence of cachexia plays an important role in the high mortality rate of cancer. Cachexia is characterized by involuntary weight loss with loss of skeletal muscle with or without loss of fat mass. The aim of this study is to determine the feasibility of taking muscle biopsies of cachectic colorectal cancer patients. Skeletal muscle characteristics will be compared between biopsies of the m. erector spinae and the m. vastus lateralis from cachectic colorectal cancer patients, non-cachectic colorectal cancer patients and healthy controls. 10 cachectic, 25 non-cachectic, and 25 healthy controls will be recruited for this study. It is an observational study, so measurements will be taken at one time point. Interventions/measurements:

• muscle biopsies
• blood samples
• 3D freehand ultrasound
• Short physical performance battery test
• handgrip strength
• questionnaires (activity pattern, quality of life)

Conditions

Colorectal Cancer; Cancer Cachexia

Keywords

colorectal cancer; cachexia; skeletal muscle; skeletal muscle fibers; capillarization

Outcome Measures

Primary Outcomes (4)

• Skeletal muscle fiber typing

  Immunofluorescence staining of skeletal muscle biopsies to observe different muscle fiber types (myosin heavy chains)

  at enrollment

• skeletal muscle nuclei

  Immunofluorescence staining with DAPI

  at enrollment

• Inflammatory parameters

  ELISA (bloodsamples), immunofluorescence staining (muscle biopsies)

  at enrollment

• Mitochondrial morphology

  mitochondrial fusion and fission (western blot) mitochondrial OXPHOS (western blot)

  at enrollment

Secondary Outcomes (8)

• 3D freehand ultrasound

  at enrollment

• CT-scans

  at enrollment

• Activity pattern

  at enrollment

• VAS score

  at enrollment

• Handgrip strength

  at enrollment

Study Arms (3)

Cachectic colorectal cancer patients

Procedure: Minimal invasive fine needle muscle biopsies

Non-cachectic colorectal cancer patients

Procedure: Minimal invasive fine needle muscle biopsies

Healthy controls

Procedure: Minimal invasive fine needle muscle biopsies

Interventions

Minimal invasive fine needle muscle biopsies PROCEDURE

Fine needle muscle biopsies will be taken from the m. erector spinae and the m. vastus lateralis. Participants are placed in a standardized prone position on the examination table for measurements of the m. erector spinae and in a supine position for measurements of the m. vastus lateralis.

Cachectic colorectal cancer patients; Healthy controls; Non-cachectic colorectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

12 cachectic colorectal cancer patients, 25 non-cachectic colorectal cancer patients, and 25 healthy controls will be recruited in the study. Colorectal cancer patients will be recruited by the surgeans from the Jessa Hospital (Hasselt, Belgium), and the healthy controls will be recruited by the local researcher from Hasselt University.

You may qualify if:

• minimum age of 18 years old
• unwanted weight loss \> 5% in the last 6 months OR \> 2% unwanted weight loss in combination with a BMI \< 20kg/m2 OR \>2% unwanted weight loss in combination with sarcopenia
• Cachexia staging score (CSS): 5-12

You may not qualify if:

• Mental of psychological condition
• Insufficient knowledge of the Dutch language
• Muscle diseases affecting the spine and lower limbs
• Bedridden
• Non-Cachectic cancer patients.
• minimum age of 18 years old
• No unwanted weight loss \> 5% in the last 6 months OR \> 2% unwanted weight loss in combination with a BMI \< 20kg/m2 OR \>2% unwanted weight loss in combination with sarcopenia
• Cachexia staging score (CSS): 0-2
• Mental of psychological condition
• Insufficient knowledge of the Dutch language
• Muscle diseases affecting the spine and lower limbs
• Bedridden
• Healthy controls.
• \- minimum age of 18 years old
• Mental of psychological condition

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (2)

Hasselt University - REVAL research institution

Diepenbeek, Limburg, 3520, Belgium

RECRUITING

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* muscle biopsies * blood samples

MeSH Terms

Conditions

Colorectal Neoplasms; Cachexia

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; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Kenneth Verboven, Professor

  Hasselt University - REVAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Britt van de Haterd, PhD student

CONTACT

0032479871509; britt.vandehaterd@uhasselt.be

Kenneth Verboven, Professor

CONTACT

kenneth.verboven@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: January 23, 2022
• Primary Completion: March 15, 2025
• Study Completion: September 10, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

BE (2)