C18 C25 Z29.21
Conditions
Interventions
Group 1: The LiMAx-Chemo Trial investigates the effect of chemotherapy on liver function using the LiMAx-Test by measuring liver function before, during and after chemotherapy with irenotecan. (Arm 1)
Sponsors
Klinik für Allgemein-, viszeral- und Tranplantationschirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients scheduled for Chemotherapy with FOLFOX (XELOX), FOLFIRI (XELIRI) or FOLFIRINOX chemotherapy protocol - Patient considered to tolerate the chemotherapy protocol - = 18 years of age - Written informed consent
Exclusion criteria
Exclusion criteria: History of adverse effects to acetaminophen - History of allergic reaction to silicone rubber - History of known open tuberculosis - History of chronic alcohol abuse - Patients with known liver cirrhosis or fibrosis of any etiology - Patients with known hepatitis C infection - Patients with known errors of metabolism such as hemochromatosis, Wilson’s Disease etc. - Patients with hereditary hyperbilirubinemia - Patients with history of prolonged intake of medication with known potential hepatotoxic side effects. - Any previously performed liver surgery. - Chemo- and/or radiotherapy during the past 6 months. - Expected lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable decrease in liver function using LiMAx Test in patients who have undergone chemotherapy with FOLFOX, FOLFIRI or FOLFIRINOX Time of measurments: - before Chemotherapy - during Chemotherapy after every 2 cycles - after termination of chemotherapy for 2 months with an intervall of 2 weeks. | — |
Countries
Germany
Contacts
Public ContactIgnazio Tarantino
Klinisches Studienzentrum der Chirurgischen Klinik (KSC)
Outcome results
None listed