Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma

Phase

N/A

Condition

Heartburn

Nasopharyngeal Cancer

Treatment

Nasogastric Tube Feeding

Intermittent Oral-esophageal Tube Feeding

comprehensive rehabilitation therapy

Clinical Study ID

NCT06265844

IOE-Biyanai

Ages 18-65
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Age between 18 and 65 years.
With the history of NPC and radiation therapy.
With dysphagia occurred at least three years after radiotherapy (confirmed byvideofluoroscopic swallowing study), in need of and feasible for enteral nutritionsupport.
Conscious and with stable vital signs;
Willing to participate and sign the written informed consent form either personally orby a family member.

Exclusion

Exclusion Criteria:

Presence of other diseases that might cause dysphagia.
With distant metastasis of tumors, or complicated with severe systemic disorders ormalignancies.
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.

Study Design

Nasogastric Tube Feeding

March 01, 2024

September 30, 2024

Study 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.

Connect with a study center

Peking University Sixth Hospital
Beijing, Beijing 101499
China
Site Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510000
China
Site Not Available
Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
China
Site Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
China
Site Not Available
Saint Martin Hospital
Hong Kong,
Hong Kong
Active - Recruiting

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