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
NCT number | NCT04199832 |
Other study ID # | 20190920 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 20, 2019 |
Est. completion date | June 30, 2022 |
Verified date | September 2022 |
Source | Tianjin Medical University Cancer Institute and Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Radiation Oncology, Tianjin Medical University cancer Institute and Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital |
China,
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 |
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