Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients (CTLm-CCP)

Hasselt University

Status: Enrolling

Conditions: Cancer Cachexia; Colorectal Cancer

Treatments: Procedure: Minimal invasive fine needle muscle biopsies

Study type: Observational

Funder types: Other

Identifiers

NCT06780423

2021/148 - CTLm-CCP

Details and patient eligibility

About

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)

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

60 participants in 3 patient groups

Cachectic colorectal cancer patients

Treatment:

Procedure: Minimal invasive fine needle muscle biopsies

Non-cachectic colorectal cancer patients

Treatment:

Procedure: Minimal invasive fine needle muscle biopsies

Healthy controls

Treatment:

Procedure: Minimal invasive fine needle muscle biopsies