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

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

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).

Study Overview

• Status: Completed
• Conditions: Enteral Nutrition; Esophageal Squamous Cell Carcinoma; Chemoradiotherapy
• Intervention / Treatment: Dietary supplement: Dietary guidance

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Department of Radiation Oncology, Tianjin Medical University cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with esophageal squamous cell carcinoma who received concurrent chemoradiotherapy voluntarily chose different nutritional treatment paths according to the degree of dysphagia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nasogastric tube; The patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube.	Dietary supplement: Dietary guidance; Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.
gastrostomy feeding; Patients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding.	Dietary supplement: Dietary guidance; Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.
Oral intake; Patients with normal swallowing or not receiving tube feeding.	Dietary supplement: Dietary guidance; Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Chair: Qingsong Pang, Doctor, Department of Radiation Oncology,Tianjin Medical University cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: 20190920

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No