NCT04199832已完成不适用
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
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2019年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Body Weight Change from baseline to the end of treatment
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Body Weight Change from baseline to the end of treatment
时间窗: up to 1 month after the treatment
Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.
次要结局
- Blood biochemical examination(up to 1 month after the treatment)
- Overall Survival(at least 2 years)
- EORTC QLQ-C30(up to 1 month after the treatment)
- Scored Patient-Generated Subjective Global Assessment (PG-SGA)(up to 1 month after the treatment)
- Grade 3-5 toxicity(up to 1 month after the treatment)
- Completion rate of chemoradiotherapy(up to 1 month after the treatment)
研究者
研究点 (1)
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