Actively Recruiting
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-04-05
210
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, open, parallel controlled clinical trial. The main purpose of this study was to compare the changes in body weight/body mass index (BMI) before and after treatment between the two groups of patients with NST full-course nutritional management and without NST full-course nutritional management. The secondary objective was to compare the quality of life, nutritional status, immune function and inflammatory response, adverse reactions of radiotherapy and chemotherapy, and short-term/long-term efficacy between the two groups. The treatment plan was: esophageal cancer with routine nutrition guidance as the control group, and the NST whole-process intervention guidance as the experimental group. 1\. Experimental group: NST whole-course intervention 1. Nutritionists formulate nutritional programs and manage them in a refined manner. On the basis of the patient's natural diet (food and homogenate meal), enteral nutritional preparations or parenteral nutritional supplements are given according to the patient's gastrointestinal obstruction, dietary structure, and food intake. Energy 30-35kcal/kg/d, protein 1.2-1.5g/kg/d. Enteral nutrition administration route: oral or tube feeding or ostomy, oral feeding is preferred; severe obstruction of eating or oral can not meet the target nutrition, choose tube feeding or ostomy. When it is expected that enteral nutrition cannot meet 60% of the target energy requirement for 3 to 5 days, choose parenteral nutrition. The enteral nutritional preparation adopts the whole protein enteral nutritional preparation Nengquan, and/or the tumor nutritional preparation Ruineng, and/or whey protein powder. 2. Radiotherapy 3. Chemotherapy 2. Control group: routine nutrition guidance for esophageal cancer (1) Nutritional therapy: The nutritional program was the same as that of the experimental group, and the patients performed it themselves. (2) Concurrent chemoradiotherapy: the same as the experimental group. Efficacy evaluation: 1. Body weight and body mass index (BMI) 2. Quality of life score (EORTCQLQ-C30) 3. Nutritional status 4. Immune function and inflammatory response (total lymphocytes, CRP, IL-6) (4) Intestinal mucosal barrier and intestinal flora (5) Adverse reactions of radiotherapy and chemotherapy (6) Short-term/long-term efficacy (5) Evaluation of treatment side effects (6) Short-term/long-term efficacy
CONDITIONS
Official Title
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and good compliance with treatment and follow-up
- Age between 18 and 75 years
- Confirmed esophageal squamous cell carcinoma by cytology or histology
- Stage II-III primary esophageal cancer without surgery (except biopsy)
- Primary tumor evaluable
- No distant organ metastasis
- PG-SGA score B (2-8) or C (≥9)
- Karnofsky Performance Status (KPS) score ≥ 70
- ECOG physical condition score 0-1
- Adequate major organ function within 7 days before treatment: Hemoglobin ≥ 100 g/L; White blood cells ≥ 4×10⁹/L; Absolute neutrophil count ≥ 1.5×10⁹/L; Platelets ≥ 100×10⁹/L
- Biochemical tests within limits: Total bilirubin ≤ 1.5 times upper limit of normal; ALT and AST ≤ 1.5 times upper limit of normal; Serum creatinine ≤ 1.5 times upper limit or creatinine clearance ≥ 60 ml/min
- Expected survival of at least 6 months
You will not qualify if you...
- No malnutrition or nutritional risk (PG-SGA score A)
- Severely impaired intestinal function or intolerance to enteral nutrition
- Severe vomiting, gastrointestinal bleeding, or intestinal obstruction
- Very severe malnutrition preventing tolerance to radiotherapy and chemotherapy
- Prior radiotherapy, chemotherapy, or targeted therapy to primary tumor or lymph nodes
- Other malignant tumors within the past 5 years except cured cervical carcinoma in situ or skin basal cell carcinoma
- Participation in other drug trials within the past month
- History of severe allergies or unusual constitution
- History of severe lung or heart disease
- Serious comorbid conditions such as uncontrolled hypertension or heart failure
- Pregnant or breastfeeding women
- Currently or planning to participate in other clinical trials
- Refusal or inability to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
X
Xiaolin Ge, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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