Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHasselt University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Mental of psychological condition
Insufficient knowledge of the Dutch language
Muscle diseases affecting the spine and lower limbs
Bedridden
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Minimal invasive fine needle muscle biopsies
Procedure/SurgeryFine 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Cachectic colorectal cancer patients1 intervention
Group B: Non-cachectic colorectal cancer patients1 intervention
Group C: Healthy controls1 intervention
Trial outcomes
Primary outcomes
1
Skeletal muscle fiber typing
Immunofluorescence staining of skeletal muscle biopsies to observe different muscle fiber types (myosin heavy chains)
Time frame
at enrollment2
skeletal muscle nuclei
Immunofluorescence staining with DAPI
Time frame
at enrollment3
Inflammatory parameters
ELISA (bloodsamples), immunofluorescence staining (muscle biopsies)
Time frame
at enrollment4
Mitochondrial morphology
mitochondrial fusion and fission (western blot) mitochondrial OXPHOS (western blot)
Time frame
at enrollmentSecondary outcomes
1
3D freehand ultrasound
measuring the volume of the m. rectus femoris
Time frame
at enrollment2
CT-scans
level lumbar 3 To calculate the cross-sectional area of the m. erector spinae.
Time frame
at enrollment3
Activity pattern
PASIPD questionnaire
Time frame
at enrollment4
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.
Time frame
at enrollmentSponsors and contacts
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Source ClinicalTrials.gov