Esophageal cancer patients
Conditions
Interventions
Experimental group:During preoperative neoadjuvant treatment and perioperative treatment, subjects followed the target-oriented nutrition support strategy for nutritional management, and only IMPACT O
Control group:Conventional nutritional support strategies
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-80 years old, male or female; 2) Physical status ECOG PS 0~1; 3) NRS 2002 score =3; 4) Malnutrition in line with GLIM standards; 5) Preoperative histopathological diagnosis of thoracic esophageal squamous cell carcinoma; 6) Resectable locally advanced esophageal cancer with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by multiple disciplines; 7) Preoperative neoadjuvant therapy is planned, including preoperative chemoradiotherapy, chemotherapy or combined immunotherapy (anti-PD-1 /PD-L1); 8) The subject understands and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1) Radical resection of esophageal cancer was performed without preoperative neoadjuvant therapy; 2) Preoperative nutritional risk was lower, NRS 2002 score < 3; 3) Combined with medical diseases that seriously affect the digestion and absorption of test products; 4) Other nutritional preparations that may affect the test effect are being used; 5) Pregnant, lactating female subjects or fertile female subjects with positive baseline pregnancy test; 6) Unable to take in nutrition orally or through tube feeding before surgery; 7) Other malignant tumors in the past 5 years (except for successfully treated basal cell skin tumors in situ and cervical tumors in situ); 8) Known abnormalities of liver and kidney function (alanine aminotransferase ALT=2 times the upper limit of normal; Total bilirubin Tbil=2 times the upper limit of normal value; Creatinine Cr=2 times the upper limit of normal value); 9) Known to have uncontrolled diabetes or fasting blood glucose =10mmol/L; 10) Known history of hypothyroidism or hyperthyroidism; 11) Subjects are using fatty milk containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents; 12) a known history of allergy to any component of the investigational product; 13) The subject refuses informed consent or is unable to follow the study protocol; 14) The researchers do not consider it appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary complication;Unplanned re-hospitalization within 90 days after surgery;Unplanned transfer to ICU within 90 days after surgery;Death of all causes occurred within 90 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major non-pulmonary complications occurred within 90 days;Serum prealbumin levels at 90 days after surgery;Body weight and body mass index at 90 days after surgery;Muscle and fat composition at 90 days after surgery;Preoperative neoadjuvant therapy for toxic and side effects;Radical resection (R0);pathological complete response, pCR;After 1, 2, 3, 5 years, no disease survived;Overall survival at 1, 2, 3 and 5 years after surgery;Quality of life 90 days after surgery;Socioeconomics benefit indicators; | — |
Countries
China
Contacts
Public ContactLi Yin
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed