Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Mar 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a special nutritional management program, called NST whole-course nutritional management, affects patients with esophageal cancer. The main goal is to see if this nutritional support helps improve patients' weight and body mass index (BMI) compared to those who receive standard nutritional advice. The trial will also look at how this program impacts quality of life, nutritional status, immune function, and side effects from treatments like chemotherapy and radiotherapy.

To be eligible for the trial, participants must be between 18 and 75 years old and diagnosed with a specific type of esophageal cancer that hasn't spread to other organs. They should have some level of nutritional risk but not be severely malnourished. Participants will be divided into two groups: one will receive the NST nutritional program tailored by nutritionists, while the other will follow standard nutritional guidance on their own. Throughout the study, participants will be monitored for changes in weight, quality of life, and any side effects from their cancer treatments. If you're interested in learning more or think you might qualify, please consult with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Sign the informed consent; must have good compliance with the treatment plan and follow-up.
• • No gender restriction, but age between 18 and 75 years old;
• • Cytological or histological is confirmed esophageal squamous cell carcinoma;
• • Non-surgical treatment of stage II-III primary esophageal cancer (except biopsy);
• • The primary tumor can be evaluated;
• • No distant organ metastasis;
• • PG-SGA score B (2\~8) or C (≥9);
• • KPS score ≥ 70 points, ECOG physical condition score 0-1 points;
• * The function of major organs (bone marrow, liver, kidney function) 7 days before treatment, meet the following criteria: Blood routine examination standards (without blood transfusion within 14 days):
• • Hemoglobin (HB) ≥ 100g/L;
• • White blood cells (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥1.5×109/L;
• • Platelet (PLT) ≥ 100×109/L.
• * The biochemical examination shall meet the following standards:
• • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
• • Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 1.5 times ULN;
• • Serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance rate (CCr) ≥ 60ml/min.
• • Expected survival ≥ 6 months.
• Exclusion Criteria:
• • No malnutrition or nutritional risk; PG-SGA score of A;
• • Severely impaired intestinal function, or intolerance of enteral nutrition;
• • Severe vomiting, gastrointestinal bleeding, intestinal obstruction;
• • Patients with very severe malnutrition cannot tolerate radiotherapy and chemotherapy;
• • The primary tumor or lymph node has received radiotherapy, chemotherapy or targeted therapy;
• • Suffering from other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or skin basal cell carcinoma);
• • Subjects who have received other drug trials within the past month;
• • Those with severe allergic history or idiosyncratic constitution;
• • Those with a history of severe lung or heart disease;
• • Serious comorbidities, such as uncontrolled hypertension, heart failure, etc.;
• • Pregnant or breastfeeding women;
• • Currently or planning to participate in other clinical trials;
• • Refusal or inability to sign the informed consent form to accept participation in the trial.