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NCT Number: NCT06780423

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

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)

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Key information

Conditions

Colorectal Cancer Body Weight Body Weight Changes Cachexia Cancer Cachexia Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasselt University - REVAL research institution, Diepenbeek, Limburg, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Skeletal muscle fiber typing

    Time frame: at enrollment

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

  2. skeletal muscle nuclei

    Time frame: at enrollment

    Immunofluorescence staining with DAPI

  3. Inflammatory parameters

    Time frame: at enrollment

    ELISA (bloodsamples), immunofluorescence staining (muscle biopsies)

  4. Mitochondrial morphology

    Time frame: at enrollment

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

Secondary outcomes

  1. 3D freehand ultrasound

    Time frame: at enrollment

    measuring the volume of the m. rectus femoris

  2. CT-scans

    Time frame: at enrollment

    level lumbar 3 To calculate the cross-sectional area of the m. erector spinae.

  3. Activity pattern

    Time frame: at enrollment

    PASIPD questionnaire

  4. VAS score

    Time frame: at enrollment

    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.

  5. Handgrip strength

    Time frame: at enrollment

    Using the JAMAR to measure the handgripstrength

  6. Short Physical Performance Battery (SPPB) test

    Time frame: at enrollment

    Including a balance test, sit-to-stand test and four meter walking test

  7. Quality of Life questionnaire

    Time frame: at enrollment

    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.

  8. skeletal muscle capillarization

    Time frame: at enrollment

    Immunofluorescence staining for capillaries in the skeletel muscle biopsies.

Study contacts

Contact information is provided by the study sponsor or research team.

Britt van de Haterd, PhD student

CONTACT

[email protected]

0032479871509

Kenneth Verboven, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Acronym: CTLm-CCP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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