Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minimal invasive fine needle muscle biopsies.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Cancer Cachexia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure 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.
Primary outcome measures
- Skeletal muscle fiber typing [Time frame: at enrollment]
- skeletal muscle nuclei [Time frame: at enrollment]
- Inflammatory parameters [Time frame: at enrollment]
- Mitochondrial morphology [Time frame: at enrollment]
Secondary outcome measures (8)
- 3D freehand ultrasound [Time frame: at enrollment]
- CT-scans [Time frame: at enrollment]
- Activity pattern [Time frame: at enrollment]
- VAS score [Time frame: at enrollment]
- Handgrip strength [Time frame: at enrollment]
- Short Physical Performance Battery (SPPB) test [Time frame: at enrollment]
- Quality of Life questionnaire [Time frame: at enrollment]
- skeletal muscle capillarization [Time frame: at enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Belgium · 2 centers
- Hasselt University - REVAL research institution — Diepenbeek
- Jessa Hospital — Hasselt
Identifiers
NCT: NCT06780423 · 2021/148 - CTLm-CCP