Effect of Nutritional Supplement in Patients with Local Advanced Nasopharyngeal Carcinoma Receiving Definitive Radio-Chemotherapy: A Prospective, Randomized, Controlled Trial (NCT02948699)

Abstract

Local advanced nasopharyngeal carcinoma (NPC) patients receiving neoadjuvant chemotherapy (NACT) and concurrent chemoradiotherapy (CCRT) suffered from insufficient nutrient intake and malnutrition. The aim of this study was to investigate the effect of whole-process enternal nutritional supplement on nutritional status, treatment tolerance, and the quality of life. NPC patients were randomly assigned to nutritional intervention group (group A) or the control group (group B). Patients in group A were supported with whole-process enteral nutrition supplement except daily diet from the beginning of radiotherapy (RT). Control group was treated with conventional diet guidance. When serious malnutrition appeared, appropriate intervention would still be given to group B according to the ESPEN guideline for the Ethical requirements. The body mass index, hematological indexes, nutritional and quality of life questionnaires as well as toxicity were collected at the baseline, before, during and after CCRT. Statistical analyses are using SPSS. From October 2016 to January 2018, 72 patients from our hospital were randomly assigned into the intervention group (n=37) and the control group (n=35). Grade 3/4 mucositis was observed in 27.8% of patients, no statistical difference between group A and B (35% vs 20%, P=0.156). The overall incidence of PG-SGA ≥4 were 20.8%, 38.9%, 69.4%, 100%, 79.3% at the baseline, after NACT, during and after radiotherapy, 1 months after RT, while weight loss were 0kg, 1.75kg, 4kg and 5kg between those time. But, PG-SGA scores and weight loss were similar between two groups. Although NRS≥3 in the control group were significantly more frequent (P=0.032) than group A after RT. However, the supplement group has no significant analysis advantages in the completion rate of CCRT, hematological indexes and the scores of NRS at these 5 observation points (P≥0.05). NACT did not improve the weight loss and malnutrition status of NPC patients. However, the malnutrition risk was gradually increased during and 1 month after CCRT. The whole process nutrition supplement has no advantage in the tolerance of CCRT and scores of short-term nutritional assessments.