C22.0 K74.6 K70.3
Conditions
Interventions
Group 1: Arm 1: Patients with hepatocellular carcinoma will undergo comprehensive assessments every 3 months over a 1-year period regarding their nutritional and muscle status, physical activity, psyc
Sponsors
Universitätsmedizin Rostock, Department für Innere Medizin, Klinik und Poliklinik für Gastroenterologie, Hepatologie und Ernährungsmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Arm 1 - HCC: New diagnosis or strong suspicion based on clinical and imaging findings (ultrasound, MRI, CT) - Arm 2 - Liver cirrhosis: Confirmed diagnosis based on a biopsy or the typical combination of clinical, laboratory, and imaging findings; if necessary, also based on shear-wave elastography with no evidence of malignancy
Exclusion criteria
Exclusion criteria: - Pregnancy or breastfeeding - Pacemaker or implanted defibrillator - Inability to complete questionnaires - Known severe comorbidities that represent a competing cause of malnutrition, sarcopenia, or death: COPD GOLD 3 or 4, heart failure NYHA 3 or 4 Pre-existing malignant tumors in addition to HCC or a well-founded suspicion thereof within the last 3 years - Conditions affecting muscle or joint function, as well as major amputations that lead to muscle atrophy or render muscle function tests unfeasible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the multimodal assessment of nutritional and muscle status in HCC patients through a combination of objective muscle quantification (ultrasound/CT/MRI as appropriate), muscle strength measurement, functional tests, body composition (bioelectrical impedance analysis), and nutritional status (24-hour recall, GLIM criteria) with the aim of identifying malnutrition and sarcopenia and their impact on disease progression, treatment response, and QoL. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Physical activity: Objective measurement using accelerometry (ActiGraph wGT3X-BT, >7 days, >10 hours/day) and self-reported data via a questionnaire (IPAQ) - Psychological distress and quality of life (QoL) assessed via questionnaires: HADS (anxiety/depression), EORTC-QLQ-C30, and QLQ-HCC18 - Molecular markers of the liver-muscle axis via plasma proteome profiles, including myokines, cytokines, and growth factors, based on longitudinal analysis of treatment-induced changes - Mechanistic relationships through the correlation between muscle and nutritional status, physical activity, psychosocial stress, and molecular markers | — |
Countries
Germany
Contacts
Public ContactKaren Rischmüller
Universitätsmedizin Rostock, Department für Innere Medizin, Klinik und Polikliinik für Gastroenterologie, Hepatologie und Ernährungsmedizin
Outcome results
None listed