Fish oil-enriched food for special medical purpose in Chinese patients with gastrointestinal tumor undergoing surgery: A multicenter, randomized, non-inferiority trial
▪ Author : Jianchun Yu, Wei Chen, Gang Xiao, Qi An, Ziyu Li, Bin Liang, Yuanxin Li, Dongbing Zhao,Junsheng Peng, Yanbing Zhou, Guole Lin, Weiming Kang, Zijian Li, Chao Yan, Yuanpei Lin, Changzhen Zhu, Hu Ren, Yijia Lin, Yulong Tian
▪ Keyword : gastrointestinal neoplasms, malnutrition, perioperative care, enteral nutrition, eicosapentaenoic acid
▪ Content : Background and Objectives: This study aimed to evaluate the safety and efficacy of a fish oil-enriched food for special medical purposes (FSMP, ProSure) compared to an oncology-specific enteral nutrition product (TPF-T). Methods and Study Design: This multicenter, randomized, open-label, non-inferiority phase III trial (NCT05301556) included patients with gastrointestinal tumors scheduled for surgery and at high risk for malnutrition. Participants were randomized 1:1 to receive either FSMP or TPF-T as a sole nutritional source from 4±2 days before surgery to 9±3 days postoperatively. The primary endpoint was the change in serum pre-albumin levels from baseline to 9±3 days post-surgery (non-inferiority margin: 20.807 mg/L).