Clinical trial · Observational
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
NCT04199832CI-TRIAL-00064017completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Enteral Nutrition | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary guidance | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Nasogastric tube
- description
- The patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube.
- interventionNames
- Dietary Supplement: Dietary guidance
- label
- gastrostomy feeding
- description
- Patients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding.
- interventionNames
- Dietary Supplement: Dietary guidance
- label
- Oral intake
- description
- Patients with normal swallowing or not receiving tube feeding.
- interventionNames
- Dietary Supplement: Dietary guidance
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDong J, Dai Z, Cao F, Zhang W, Zhang T, Chen X, Chen Y, Zhao F, Li J, Du Q, Zhang K, Zeng Y, Li C, Wang Y, Li Y, Wang K, Pang Q. Effects of PEG in patients with esophageal squamous cell carcinoma during concurrent chemoradiotherapy: a prospective study. Gastrointest Endosc. 2023 Dec;98(6):901-910.e3. doi: 10.1016/j.gie.2023.04.2094. Epub 2023 May 5. PMID 37150411