A Randomly Controlled Study to Explore Effect of Oral Enteral Nutrition in Nasopharyngeal Carcinoma Survivors With Swallowing Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- concentration of Serum prealbumin
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 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.
研究组 & 干预措施
Intermittent Oral-esophageal Tube Feeding
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on the patients; health condition. The observation group receives Intermittent Oro-esophageal Tube Feeding for enteral nutrition support
干预措施: Intermittent Oral-esophageal Tube Feeding (Device)
Intermittent Oral-esophageal Tube Feeding
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on the patients; health condition. The observation group receives Intermittent Oro-esophageal Tube Feeding for enteral nutrition support
干预措施: comprehensive rehabilitation therapy (Behavioral)
Nasogastric Tube Feeding
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on the patients; health condition.The control group receives nasogastric tube for enteral nutrition support
干预措施: comprehensive rehabilitation therapy (Behavioral)
Nasogastric Tube Feeding
During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on the patients; health condition.The control group receives nasogastric tube for enteral nutrition support
干预措施: Nasogastric Tube Feeding (Device)
结局指标
主要结局
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)
concentration of Serum albumin
时间窗: day 1 and day 15
Serum albumin was recorded through the blood routine test. (ALB, g/L)
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
次要结局
- Depression(day 1 and day 15)
- Penetration-Aspiration Scale(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
- Feeding amount(day 1 and day 15)
研究者
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital