NCT06780423 Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
| NCT ID | NCT06780423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hasselt University |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-01-23 |
| Primary Completion | 2025-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-01-23 with a primary completion date of 2025-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Kenneth Verboven, Professor
PRINCIPAL INVESTIGATOR
Hasselt University - REVAL
Frequently Asked Questions
Who can join the NCT06780423 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06780423 currently recruiting?
Yes, NCT06780423 is actively recruiting participants. Contact the research team at britt.vandehaterd@uhasselt.be for enrollment information.
Where is the NCT06780423 trial being conducted?
This trial is being conducted at Diepenbeek, Belgium, Hasselt, Belgium.
Who is sponsoring the NCT06780423 clinical trial?
NCT06780423 is sponsored by Hasselt University. The principal investigator is Kenneth Verboven, Professor at Hasselt University - REVAL. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.