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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199832
• Other study ID #: 20190920
• Status: Completed
• Start date: December 20, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Chemoradiotherapy
• Enteral Nutrition
• Esophageal Squamous Cell Carcinoma

Intervention

Dietary Supplement:
• Dietary guidance
Dietary guidance for feeding tube patients with food homogenate,dietary guidance for patients with oral feeding.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Tianjin Medical University cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood biochemical examination	albumin,prealbumin,haemoglobin,et al, record the changes before and after the treatment.	up to 1 month after the treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Completion rate of chemoradiotherapy	The proportion of people who complete all treatment as required	up to 1 month after the treatment
Secondary	Overall Survival	overall survival	at least 2 years