PB2291 ENTERAL VERSUS PARENTERAL NUTRITION IN ADULT HEMATOPOIETIC CELL TRANSPLANTATION RECIPIENTS SUFFERING FROM GASTROINTESTINAL MUCOSITIS

Background: Gastrointestinal (GI) mucositis is a severe side effect of intensive chemotherapy (ICT) and/or radiotherapy and is associated with nutrient maldigestion and malabsorption. Clinically, patients with mucositis suffer from anorexia, diarrhea, abdominal pain and weight loss. A standardized, validated and effective feeding strategy for these patients is currently lacking. Preclinical studies in rats, with GI mucositis, showed that enteral feeding was superior as compared to parenteral feeding with regards to preservation of gut mucosa integrity. Total parenteral nutrition (TPN) is predominantly used in adults treated with ICT and hematopoietic cell transplantation (HCT) albeit without evidence indicating superiority of TPN over enteral nutrition (EN). Aims: We performed a prospective randomized single centre clinical trial (RCT), comparing two feeding strategies (TPN or EN) in HCT adults. Primary objectives were to determine differences in nutritional status and gut mucosal barrier. Secondary objectives were treatment‐related complications (febrile neutropenia (FN), bacteraemia, inflammation). Methods: Adult patients ( 3 18 years of age), admitted to the Radboud University Medical Center Nijmegen for treatment with an autologous (a)HCT following conditioning with high‐dose melphalan (HDM) or carmustine, etoposide, cytarabine and melphalan (BEAM), were eligible for inclusion. Exclusion criteria were pre‐existing bowel diseases, BMI <18 (kg/cm2), serum albumin <20 g/l and creatinine clearance < 50 ml/min. Patients were randomized to receive either EN or TPN. An elementary tube diet was administered by continuous enteral drip through a naso‐gastric tube (EN group). TPN was administered via a central venous catheter. TPN is the current clinical practice in adults and therefore designated the standard regimen (TPN group). Primary endpoints were changes in nutritional status (Dbodyweight and Dmid‐upper arm circumference (DMUAC) on day +28, and severity of GI mucositis (nadir citrulline levels). Secondary endpoints include treatment‐related complications (FN, bacteraemia,inflammation). Results: Between September 2014 and January 2018 the planned 34 adult patients were included. Six patients were not evaluable because they did not tolerate EN or lost their naso‐gastric tube within 48 hours of placement, but as defined in the protocol they were replaced by 6 additional patients although 3 of them also proved unevaluable. Finally 31 patients were evaluable, 11 patients received EN and 20 patients received TPN. Median age was 59 (44‐69) years, and most patients were male (77.4%). All received an aHCT with HDM (18 patients) or BEAM (13 patients). The Dbodyweight on day +28 post‐HCT was ‐4.02 kg in the EN and ‐3.68 kg in the TPN group (absolute difference ‐0.34 kg; CI 95% ‐2.6 – 1.99, p = 0.77). The DMUAC on day +28 was ‐1.41 cm in the EN and ‐1.02 cm in the TPN group (absolute difference ‐0.39 cm; CI 95% ‐1.38 – 0.60, p = 0.43). The course of citrulline levels was comparable, with a nadir of citrulline of 2.3 in the EN and 2.2 in the TPN group respectively. The mean duration of neutropenia was 15.36 days in EN and 16.35 days in TPN ( p  = 0.77). Incidence of FN was 9 in the EN group and 14 in the TPN group (p = 0.53). There were no differences in patients with a bacteraemia between the EN (3 patients) and the TPN group (7 patients) (p = 0.75). Summary/Conclusion: Although preclinical studies suggest a beneficial role of EN in patients with GI mucositis in this RCT with adult HCT recipients tolerability and feasibility was poor and efficacy could not be established (although underpowered).