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

NCT ID: NCT06780423

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-23
• Study Completion Date: 2025-09-10

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cachectic colorectal cancer patients

Minimal invasive fine needle muscle biopsies

Intervention Type: 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.

Non-cachectic colorectal cancer patients

Minimal invasive fine needle muscle biopsies

Intervention Type: 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.

Healthy controls

Minimal invasive fine needle muscle biopsies

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• 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

Non-Cachectic cancer patients.

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

Healthy controls.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Kenneth Verboven

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Verboven, Professor

Role: PRINCIPAL_INVESTIGATOR

Hasselt University - REVAL

Locations

Hasselt University - REVAL research institution

Diepenbeek, Limburg, Belgium

Site Status: RECRUITING

Jessa Hospital

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Britt van de Haterd, PhD student

Role: CONTACT

britt.vandehaterd@uhasselt.be

0032479871509

Kenneth Verboven, Professor

Role: CONTACT

kenneth.verboven@uhasselt.be

Facility Contacts

Kenneth Verboven, Professor

Role: primary

kenneth.verboven@uhasselt.be

+3211269315

Britt van de Haterd, PhD student

Role: backup

britt.vandehaterd@uhasselt.be

0032479871509

Bert Houben, Doctor

Role: primary

bert.houben@jessazh.be

+3211 33 75 19

Other Identifiers

2021/148 - CTLm-CCP

Identifier Type: -

Identifier Source: org_study_id