Goal-directed Enteral Nutritional Perioperative Management

Korábbi kezelés

• Upfront surgery without neoadjuvant treatment;
• Receiving any other nutritional support during the study;
• Unable to consume nutrition orally or receive it through tube feeding before surgery;
• Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents

Más betegség

• History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
• History of known allergy to any component of ORAL IMPACT®;

Laborértékek

• Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit of normal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit of normal);
• Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;

Egyéb

• NRS 2002 score < 3;
• Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
• Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test at baseline or not using a reliable and appropriate contraceptive method;
• Refuse to sign the consent or unable to follow the study protocol;
• Inappropriate to participate in this study judged by investigators.

• Aged 18-80 years old;
• ECOG PS 0~1;
• NRS 2002 score ≥3;
• Malnutrition diagnosed according to the GLIM criteria;
• Histopathologically confirmed as esophageal squamous cell carcinoma;
• Primary tumors located in thoracic esophagus;
• Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by a multidisciplinary team;
• Neoadjuvant therapy will be administered, which may entail preoperative chemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such as anti-PD-1/PD-L1;
• Informed consent for random assignment and completion of the protocol.