Examining muscle characteristics in colorectal cancer patients with cachexia
Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
Hasselt University · NCT06780423
This study looks at the muscles of colorectal cancer patients with and without cachexia to see how they differ from healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hasselt University (other) |
| Locations | 2 sites (Diepenbeek, Limburg and 1 other locations) |
| Trial ID | NCT06780423 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the structural characteristics of trunk and limb muscles in cachectic colorectal cancer patients compared to non-cachectic patients and healthy controls. The study will involve taking minimal invasive fine needle muscle biopsies from the m. erector spinae and m. vastus lateralis muscles. A total of 60 participants will be recruited, including 10 cachectic patients, 25 non-cachectic patients, and 25 healthy controls, with measurements taken at a single time point to evaluate muscle characteristics and their implications in cancer cachexia.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with cachexia associated with colorectal cancer.
Not a fit: Patients with mental or psychological conditions, muscle diseases affecting the spine and lower limbs, or those who are bedridden may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of muscle deterioration in cachectic colorectal cancer patients, potentially leading to improved management strategies.
How similar studies have performed: While studies on cachexia and muscle characteristics exist, this specific approach of comparing muscle biopsies across different patient groups is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Diepenbeek, Limburg and 1 other locations
- Hasselt University - REVAL research institution — Diepenbeek, Limburg, Belgium (RECRUITING)
- Jessa Hospital — Hasselt, Limburg, Belgium (RECRUITING)
Study contacts
- Principal investigator: Kenneth Verboven, Professor — Hasselt University - REVAL
- Study coordinator: Britt van de Haterd, PhD student
- Email: britt.vandehaterd@uhasselt.be
- Phone: 0032479871509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, Cancer Cachexia, colorectal cancer, cachexia, skeletal muscle, skeletal muscle fibers, capillarization