Intermittent Oral-esophageal Tube in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional

Summary: 
      This is a prospective multicenter study with patients with delayed dysphagia after
      radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation
      group and the control group. All patients receive conventional care, and the observation
      group received IOE while the control group received NGT for enteral nutrition support.
      Baseline information (demographics, medical history, etc.), nutritional status at admission
      and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well
      as adverse events are compared.
    

Detailed description: 
      Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC)
      continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely,
      the weaknesses have yet to be improved by another enteral nutrition support mode. This study
      aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in
      the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective
      multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients
      enrolled are randomly divided equally into the observation group and the control group. All
      patients receive conventional care, and the observation group received IOE while the control
      group received NGT for enteral nutrition support. Baseline information (demographics, medical
      history, etc.), nutritional status at admission and after treatment, depression, dysphagia,
      and quality of life (QOL) after treatment as well as adverse events are compared.
    

Intervention name(s): Intermittent Oral-esophageal Tube Feeding; nasogastric tube feeding
Intervention type(s): Device; Device
Intervention description(s): 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 health condition.The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support (developed by the Dysphagia Institute of Zhengzhou University, CN201821314797.2), which is made of silicone material, 40 cm long, with an inner diameter of 0.54 cm.; 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 health condition.The control group is provided with nutritional support as nasogastric tube feeding, performed 6-10 times per day according to relevant guidelines, with an interval of more than 2 hours between every two feedings, and a feeding volume not exceeding 200 ml per time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care