Clinical trial NCT04199832: To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Squamous Cell Carcinoma
Chemoradiotherapy
Enteral Nutrition
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Body Weight Change from baseline to the end of treatment
timeFrame: up to 1 month after the treatment
Secondary outcomes:
measure: Blood biochemical examination
timeFrame: up to 1 month after the treatment
measure: Scored Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: up to 1 month after the treatment
measure: EORTC QLQ-C30
timeFrame: up to 1 month after the treatment
measure: Grade 3-5 toxicity
timeFrame: up to 1 month after the treatment
measure: Completion rate of chemoradiotherapy
timeFrame: up to 1 month after the treatment
measure: Overall Survival
timeFrame: at least 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Department of Radiation Oncology, Tianjin Medical University cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Department of Radiation Oncology,Tianjin Medical University cancer Institute and Hospital
name: Qingsong Pang, Doctor
role: STUDY_CHAIR
References: