Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Enteral Nutrition
Conditions
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTDietary guidance
Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Change from baseline to the end of treatment | up to 1 month after the treatment | Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scored Patient-Generated Subjective Global Assessment (PG-SGA) | up to 1 month after the treatment | Nutritional status evaluation table. score: 0-1 A: well-nourished; score：2-8 B: moderately malnourished; score：≥9 C: severely malnourished. |
| EORTC QLQ-C30 | up to 1 month after the treatment | 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. |
| Blood biochemical examination | up to 1 month after the treatment | albumin,prealbumin,haemoglobin,et al, record the changes before and after the treatment. |
| Completion rate of chemoradiotherapy | up to 1 month after the treatment | The proportion of people who complete all treatment as required |
| Overall Survival | at least 2 years | overall survival |
| Grade 3-5 toxicity | up to 1 month after the treatment | 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 |
Countries
China
Outcome results
None listed