Esophageal cancer
Conditions
Interventions
Early intervention group:Early whole-course nutritional intervention
Nomal intervention group:Whole-course nutritional intervention
Control group:Normal diet
Sponsors
Gansu Provincal Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 to 70 years; 2. Patients with ECoG score of 0-2; 3. Patients with an expected survival time of no less than 12 weeks; 4. Patients with local advanced esophageal cancer with initially diagnosed and treatedand pathologically(histology or cytology) confirmed as squamous cell carcinoma; 5.The blood routine examination standard should meet the following requirements: WBC >= 4.0 x 10^9/L; ANC >= 2.0 x 10^9/L; PLT >= 100x10^9/L; HB >= 80g/L; Biochemical examination should meet the following standards: TBIL <= 1.5 ULN, ALT and AST < 2.5 ULN, CR <= 1.2ULN,BUN <= 1.2ULN; 6. Patients can lose weight, but less than 10% and diet decreased, but was 60% higher than the target; 7. Women of childbearing age were required to have a serum pregnancy test within 3 days before the start of the study, and the results were negative, and they were willing to use a medically recognized high-efficiency contraceptive method (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug; for male subjects whose partners were women of childbearing age, surgical sterilization was required, Or agree to use effective contraceptive methods during the study and within 3 months after the last study administration; 8. The subjects volunteered to join the study and signed the informed consent. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with severe malnutrition (weight loss of > 10% or blood albumin < 30g/L or BMI < 18.5kg/m2); 2. Those who have serious heart, lung and brain diseases and are unable to undergo radiotherapy; 3. Patients with esophageal perforation (esophageal tracheal fistula or possible esophageal aortic fistula), complete esophageal obstruction, active esophageal bleeding or previous massive esophageal bleeding; 4. Patients with chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, etc.; 5. Patients with fever associated with infection; 6. Patients with known cases of allergy to or intolerance to any ingredient of parenteral nutrition used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions and short-term efficacy of chemoradiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutrition-related indicators;Immune-related indicators; | — |
Countries
China
Contacts
Public ContactSong Haixia
Gansu Provincal Cancer Hospital
Outcome results
None listed