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

T

Tianjin Medical University

Status

Completed

Conditions

Enteral Nutrition
Chemoradiotherapy
Esophageal Squamous Cell Carcinoma

Treatments

Dietary Supplement: Dietary guidance

Study type

Observational

Funder types

Other

Identifiers

NCT04199832
20190920

Details and patient eligibility

About

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).

Enrollment

156 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

156 participants in 3 patient groups

Nasogastric tube
Description:
The patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube.
Treatment:
Dietary Supplement: Dietary guidance
gastrostomy feeding
Description:
Patients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding.
Treatment:
Dietary Supplement: Dietary guidance
Oral intake
Description:
Patients with normal swallowing or not receiving tube feeding.
Treatment:
Dietary Supplement: Dietary guidance

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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