EARLY INTRAVENOUS ADMINISTRATION OF NUTRITIONAL SUPPORT (IVANS) IN METASTATIC GASTRIC CANCER PATIENTS AT NUTRITIONAL RISK, UNDERGOING FIRST-LINE CHEMOTHERAPY: A PRAGMATIC, RANDOMIZED, MULTICENTER, PARALLEL-GROUP, CLINICAL TRIAL

It is well known that cancer may affect nutritional status, especially in patients with advanced-stage disease. There is strong evidence in the literature about the prognostic effect of nutritional status on the clinical outcomes of patients receiving oncological treatment and even in terminal-stage disease. Nutritional support is recognized as a useful clinical practice to enhance the nutritional status and improve the outcomes of patients with cancer. Guidelines have been published in order to provide the proper support in each setting. Recommendations are given with various grades of evidence in different patient categories, and, in particular, in patients undergoing anticancer systemic treatment, recommendations have a very low level of evidence. Of note, although many reviews have been published about the role of nutrition support in patients with cancer, involving counseling, oral nutrition supplements, enteral nutrition (EN), and parenteral nutrition (PN), on the other hand, the role of PN only has been investigated mainly in surgical series or in the palliative setting. The present research is made up of two parts. First, we decided to systematically review published literature and perform a meta-analysis on clinical outcomes in patients receiving supplemental PN (SPN) during chemotherapy. The results confirmed the small number of studies investigating the impact of SPN during chemotherapy and the lack of studies exploring the role of the early administration of SPN in combination with nutritional counseling (NC) in this setting. The need for larger randomized clinical trials (RCT), hopefully homogeneous for cancer subgroups, led us to design and conduct the IVANS protocol, which was designed to avoid major biases observed in most of the studies included in the previously performed systematic review. Therefore, the second part of the present project is aimed at evaluating the efficacy - in terms of survival, weight maintenance, body composition, and QoL - and feasibility of cancer therapy of early systematic SPN in combination with NC. We compared the study arm and the control arm with NC alone, enrolling patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy (CT), as planned in the ongoing IVANS protocol.