Clinical trial NCT06780423: Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
Official title: Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Cancer Cachexia
Keywords: colorectal cancer
cachexia
skeletal muscle
skeletal muscle fibers
capillarization
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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)


Eligibility 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

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

Primary outcomes:
measure: Skeletal muscle fiber typing
timeFrame: at enrollment
measure: skeletal muscle nuclei
timeFrame: at enrollment
measure: Inflammatory parameters
timeFrame: at enrollment
measure: Mitochondrial morphology
timeFrame: at enrollment
Secondary outcomes:
measure: 3D freehand ultrasound
timeFrame: at enrollment
measure: CT-scans
timeFrame: at enrollment
measure: Activity pattern
timeFrame: at enrollment
measure: VAS score
timeFrame: at enrollment
measure: Handgrip strength
timeFrame: at enrollment
measure: Short Physical Performance Battery (SPPB) test
timeFrame: at enrollment
measure: Quality of Life questionnaire
timeFrame: at enrollment
measure: skeletal muscle capillarization
timeFrame: at enrollment
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University - REVAL research institution
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Hasselt University - REVAL
name: Kenneth Verboven, Professor
role: PRINCIPAL_INVESTIGATOR
References: