To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy

Study Overview
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Brief Summary
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This study prospectively recruited esophageal squamous-cell carcinoma patients who received nasogastric tube (NG), gastrostomy feeding and oral intake to compare the changes in nutritional status and quality of life during chemoradiation therapy (CRT).

Official Title
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Nutritional Status and Complications in Patients Undergoing Chemoradiotherapy for Esophageal Squamous Cell Carcinomas: a Comparison of Nasogastric Tube, Percutaneous Endoscopic Gastrostomy Tube and Oral Supplement

Conditions
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Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Enteral Nutrition

Intervention / Treatment
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* Dietary Supplement: Dietary guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically or cytologically proven esophageal squamous cell carcinoma Karnofsky performance score(KPS) ≧70 Concurrent chemoradiotherapy Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal Creatinine normal OR creatinine clearance ≥ 60 mL/min Patients have good compliance to treatment and follow-up of acceptance the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications Exclusion Criteria: Patients with severely bowel function impaired or can not tolerate enteral nutrition Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction Patients who have distant metastasis The primary tumor or lymph node already received surgical treatment efuse or incapable to sign the informed consent form of participating this trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nasogastric tube<br>The patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube. | Dietary Supplement: Dietary guidance<br>* Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.<br>|
| gastrostomy feeding<br>Patients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding. | Dietary Supplement: Dietary guidance<br>* Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.<br>|
| Oral intake<br>Patients with normal swallowing or not receiving tube feeding. | Dietary Supplement: Dietary guidance<br>* Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight Change from baseline to the end of treatment | Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight. | up to 1 month after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood biochemical examination | albumin,prealbumin,haemoglobin,et al, record the changes before and after the treatment. | up to 1 month after the treatment | 
| Scored Patient-Generated Subjective Global Assessment (PG-SGA) | Nutritional status evaluation table. score: 0-1 A: well-nourished; score：2-8 B: moderately malnourished; score：≥9 C: severely malnourished. | up to 1 month after the treatment | 
| EORTC QLQ-C30 | Quality of life evaluation form. QLQ-C30 results were linearly transformed to scores 0 to 100. Higher scores represent worse symptoms in the symptom scales and better function in functional scales. | up to 1 month after the treatment | 
| Grade 3-5 toxicity | Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 andthe criteria of the Radiation Therapy Oncology Group ，such as esophagitis、pneumonitis 、hematologic toxicity and infection rate | up to 1 month after the treatment | 
| Completion rate of chemoradiotherapy | The proportion of people who complete all treatment as required | up to 1 month after the treatment | 
| Overall Survival | overall survival | at least 2 years |