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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06780423
Acronym
CTLm-CCP
Enrollment
60
Registered
2025-01-17
Start date
2022-01-23
Completion date
2025-09-10
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Cachexia, Colorectal Cancer

Keywords

colorectal cancer, cachexia, skeletal muscle, skeletal muscle fibers, capillarization

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)

Interventions

PROCEDUREMinimal 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.

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Skeletal muscle fiber typingat enrollmentImmunofluorescence staining of skeletal muscle biopsies to observe different muscle fiber types (myosin heavy chains)
skeletal muscle nucleiat enrollmentImmunofluorescence staining with DAPI
Inflammatory parametersat enrollmentELISA (bloodsamples), immunofluorescence staining (muscle biopsies)
Mitochondrial morphologyat enrollmentmitochondrial fusion and fission (western blot) mitochondrial OXPHOS (western blot)

Secondary

MeasureTime frameDescription
Handgrip strengthat enrollmentUsing the JAMAR to measure the handgripstrength
Short Physical Performance Battery (SPPB) testat enrollmentIncluding a balance test, sit-to-stand test and four meter walking test
3D freehand ultrasoundat enrollmentmeasuring the volume of the m. rectus femoris
skeletal muscle capillarizationat enrollmentImmunofluorescence staining for capillaries in the skeletel muscle biopsies.
Quality of Life questionnaireat enrollmentSF-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.
CT-scansat enrollmentlevel lumbar 3 To calculate the cross-sectional area of the m. erector spinae.
Activity patternat enrollmentPASIPD questionnaire
VAS scoreat enrollmentto 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.

Countries

Belgium

Contacts

Primary ContactBritt van de Haterd, PhD student
britt.vandehaterd@uhasselt.be0032479871509
Backup ContactKenneth Verboven, Professor
kenneth.verboven@uhasselt.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026