NCT06189482

Intermittent Oral-esophageal Tube Feeding in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma

Clinical Observation of Intermittent Oral-esophageal Tube Feeding in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma: A Randomly Controlled Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Zeng Changhao · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Carcinoma
• Dysphagia

Interventions

Type	Name	Description
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 IOE for enteral nutrition support (developed by the Dysphagia Institute of Zhengzhou University, CN201821314797.2, as shown in the Appendix), which is made of silicone material, 40 cm long, with an inner diameter of 0.54 cm.
DEVICE	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 is provided with nutritional support as NGT, 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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-25
• Completion: 2022-12-31
• First posted: 2024-01-03
• Last updated: 2024-03-12

Locations

1 site across 1 country: China