C22
Conditions
Interventions
Group 1: Follow-up observation of patients with hepatocellular carcinoma (HCC) at intervals of approximately 3 months, including assessment of malnutrition and sarcopenia, BIA, muscle strength, and mu
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: Diagnosis of HCC based on clinical and imaging methods (sonography, NMR, CT)
Exclusion criteria
Exclusion criteria: - Pregnancy or breastfeeding - Pacemaker or implanted defibrillator - Insufficient ability to answer questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Prevalence of malnutrition and sarcopenia in the course of the tumor disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference pre-post after ~3, 6 months and possibly further time points after study inclusion: - Staging of underlying liver disease and HCC (MELD score, Child Pugh stage, TNM classification, BCLC stage, ALBI score, mRECIST, ECOG performance status) - Mortality and hospital readmissions - Determination of overall survival (OS) and progression-free survival (PFS) - Delta prevalence of diagnosis of malnutrition (GLIM criteria) and sarcopenia (EWGSOP2 criteria) - Delta prevalence of reduced skeletal muscle mass (70 years), unintentional weight loss (> 10 % regardless of the period or > 5 % in the last 3-6 months), reduced fat-free mass index (FFMI) < 15 kg/m2 (??), < 17 kg/m2 (??)) of the patients at the different time points - Difference in anthropometric parameters (body weight (kg), BMI (kg/m2), upper arm and calf circumference (cm)) - Differences in body composition (BIA): Fat mass (FM(I)), fat-free mass (FFM(I)), skeletal muscle mass (SMM(I)), body water (TBW), extracellular water (ECW), phase angle - Muscle strength via hand grip strength (kg) as the highest value of 3 measurements - Muscle function based on walking speed (4m walking distance, m/s) - Physical activity (IPAQ questionnaire); METs per day, activity level - Clinical-chemical blood analysis | — |
Countries
Germany
Contacts
Public ContactGeorg Lamprecht
Universitätsmedizin Rostock, Department für Innere Medizin, Klinik und Poliklinik für Gastroenterologie, Hepatologie und Ernährungsmedizin
Outcome results
None listed