This phase IV trial studies APAP-CYS concentrations in primary or secondary liver cancer patients with non-acetaminophen induced liver injury after taking therapeutic doses of acetaminophen. This research may help doctors in the future better understand protein adduct concentrations in patient’s blood.
Additional locations may be listed on ClinicalTrials.gov for NCT02911961.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To describe the course of acetaminophen-cysteine protein adduct (APAP-CYS) concentrations following ischemic hepatic embolization in subjects who receive 2 or 4 grams/day of acetaminophen for three days prior to the procedure.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients with metastatic hepatic tumor receive acetaminophen orally (PO) 4 times daily (QID) on days -3 to -1 prior to standard embolization. Patients with primary hepatic tumor receive acetaminophen PO twice daily (BID) on days -3 to -1 prior to standard embolization Patients also receive a medication diary to record the number of times they take acetaminophen, any other medication, or alcohol.
GROUP II: Patients undergo standard embolization.
After completion of study, patients are followed up at 9 and 14 days.
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorKennon Heard