A Randomly Controlled Study to Explore the Effect of Oral Feeding in Dysphagia for Nasopharyngeal Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age between 18 and 65 years.

• With the history of NPC 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.

Locations
Other Locations
Hong Kong Special Administrative Region
Saint Martin Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Hongji Zeng, Master
535226944@qq.com
17695841016
Backup
Weijia Zhao, Master
zwjww2009@163.com
17839973473
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 80
Treatments
Experimental: The observation group
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
Active_comparator: The control group
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
Sponsors
Leads: Zeng Changhao

This content was sourced from clinicaltrials.gov