Graft-versus-host disease (GvHD) of the gastrointestinal tract after reduced intensity conditioning (RIC) allogenic stem cell transplantation, based on an immunological reaction of donor immune cells against host tissues, leads to significant morbidity and mortality. Fish oil is known for its immunomodulatory effects and seems beneficial in several inflammatory diseases. In this pilot study, the feasibility and safety of intermittent parenteral fish oil administration in patients with gastro-intestinal GvHD will be investigated. The main objective is to study feasibility, safety and effects on plasma and white blood cell (WBC) membrane fatty acid profiles of intermittent fish oil infusion. Moreover, nutritional status and clinical parameters will be assessed. The study population will consist of five patients with severe graft versus host disease of the gastrointestinal tract after RIC. At the hematology day care unit, intermittent infusion of a 10% w -3-lipid emulsion (fish oil–based; Omegaven Ò , Fresenius-Kabi) will be performed via central or peripheral venous catheter. At day 1, 1.5 ml/kg body weight (BW), at day 3, 2.25 ml/kg BW and at day 5, 8, 10 and 12, 3 ml/kg BW will be infused during 4 hours. After day 12, an observation period of two weeks will follow.
Concerned persons: B.S van der Meij, J.A.E. Langius, M.A.E. van Bokhorst - de van der Schueren, O.J. Visser, P.C. Huijgens and professor P.A.M. van Leeuwen
E-mail: b.vandermeij@vumc.nl , o.visser@vumc.nl , pam.vanleeuwen@vumc.nl