A Randomly Controlled Study to Explore the Effect Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.
详细描述
Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma continues to be a challenge. This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •With the history of Nasopharyngeal Carcinoma and radiation therapy.
- •With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support.
- •Conscious and with stable vital signs;
- •Willing to participate and sign the written informed consent form either personally or by a family member.
排除标准
- •Presence of other diseases that might cause dysphagia.
- •With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
- •Concurrent participation in other treatments that could interfere with the trial.
- •Inability to cooperate with treatment due to aphasia, mental health issues, etc.
- •Received tube feeding for enteral nutrition support within the past three years.
结局指标
主要结局
Body Mass Index
时间窗: day 1 and day 15
Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2
concentration of Serum albumin
时间窗: day 1 and day 15
Serum albumin was recorded through the blood routine test. (ALB, g/L)
concentration of Serum prealbumin
时间窗: day 1 and day 15
Serum prealbumin was recorded through the blood routine test.(PA, g/L)
concentration of Hemoglobin
时间窗: day 1 and day 15
Hemoglobin was recorded through the blood routine test. (Hb, g/L)
次要结局
- Depression(day 1 and day 15)
- Swallowing-Quality of Life questionnaire(day 1 and day 15)
- Feeding amount(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
- Penetration-Aspiration Scale(day 1 and day 15)
研究者
Zeng Changhao
Principle Investigator
People's Hospital of Zhengzhou University