Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients (CTLm-CCP)

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)

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Cancer Cachexia
• Intervention / Treatment: Procedure: Minimal invasive fine needle muscle biopsies

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Britt van de Haterd, PhD student; Phone Number: 0032479871509; Email: britt.vandehaterd@uhasselt.be
• Study Contact Backup: Name: Kenneth Verboven, Professor; Email: kenneth.verboven@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3520
      • Recruiting
      • Hasselt University - REVAL research institution
      • Contact: Britt van de Haterd, PhD student; Phone Number: 0032479871509; Email: britt.vandehaterd@uhasselt.be
      • Contact: Kenneth Verboven, Professor; Phone Number: +3211269315; Email: kenneth.verboven@uhasselt.be
      • Sub-Investigator: Britt van de Haterd, PhD student
      • Principal Investigator: Kenneth Verboven, Professor
      • Sub-Investigator: Anouk Agten, Professor
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Contact: Bert Houben, Doctor; Phone Number: +3211 33 75 19; Email: bert.houben@jessazh.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Cachectic colorectal cancer patients.

Inclusion criteria:

• 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

Exclusion Criteria:

• Mental of psychological condition
• Insufficient knowledge of the Dutch language
• Muscle diseases affecting the spine and lower limbs
• Bedridden

Non-Cachectic cancer patients.

Inclusion criteria:

• 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

Exclusion criteria:

• Mental of psychological condition
• Insufficient knowledge of the Dutch language
• Muscle diseases affecting the spine and lower limbs
• Bedridden

Healthy controls.

Inclusion criteria:

- minimum age of 18 years old

Exclusion criteria:

• Mental of psychological condition
• Insufficient knowledge of the Dutch language
• Muscle diseases affecting the spine and lower limbs
• Bedridden

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	Procedure: Minimal invasive fine needle muscle biopsies; 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	Procedure: Minimal invasive fine needle muscle biopsies; 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.
Non-cachectic colorectal cancer patients	Procedure: Minimal invasive fine needle muscle biopsies; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Skeletal muscle fiber typing	Immunofluorescence staining of skeletal muscle biopsies to observe different muscle fiber types (myosin heavy chains)	at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D freehand ultrasound	measuring the volume of the m. rectus femoris	at enrollment
Activity pattern	PASIPD questionnaire	at enrollment
Handgrip strength	Using the JAMAR to measure the handgripstrength	at enrollment
Short Physical Performance Battery (SPPB) test	Including a balance test, sit-to-stand test and four meter walking test	at enrollment
CT-scans	level lumbar 3 To calculate the cross-sectional area of the m. erector spinae.	at enrollment
VAS score	to descripe the pain at the moment of the biopsy procedure. Score range is 0 to 10. With 0 no pain until 10 the worst pain.	at enrollment
Quality of Life questionnaire	SF-36 questionnaire 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.	at enrollment
skeletal muscle capillarization	Immunofluorescence staining for capillaries in the skeletel muscle biopsies.	at enrollment

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Kenneth Verboven, Professor, Hasselt University - REVAL

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2022
• Primary Completion (Actual): March 15, 2025
• Study Completion (Estimated): September 10, 2025

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; cachexia; skeletal muscle; skeletal muscle fibers; capillarization
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Body Weight; Intestinal Diseases; Body Weight Changes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Colorectal Neoplasms; Cachexia
• Other Study ID Numbers: 2021/148 - CTLm-CCP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No