To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy
- Conditions
- Esophageal Squamous Cell CarcinomaChemoradiotherapyEnteral Nutrition
- Interventions
- Dietary Supplement: Dietary guidance
- Registration Number
- NCT04199832
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Nasogastric tube Dietary guidance The patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube. gastrostomy feeding Dietary guidance Patients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding. Oral intake Dietary guidance Patients with normal swallowing or not receiving tube feeding.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Blood biochemical examination up to 1 month after the treatment albumin,prealbumin,haemoglobin,et al, record the changes before and after the treatment.
Overall Survival at least 2 years overall survival
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.
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.
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
Completion rate of chemoradiotherapy up to 1 month after the treatment The proportion of people who complete all treatment as required
Trial Locations
- Locations (1)
Department of Radiation Oncology, Tianjin Medical University cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China