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

NCT06189482 | Terminated DMC

• 2 other identifiers: 2022-KY-00492020-PT310-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma; Dysphagia

Outcome Measures

Primary Outcomes (5)

• Hemoglobin

  Hemoglobin was recorded through the blood routine test. (Hb, g/L)

  day 1 and day 15

• Serum albumin

  Serum albumin was recorded through the blood routine test. (ALB, g/L)

  day 1 and day 15

• Total serum protein

  Total serum protein was recorded through the blood routine test. (TP, g/L)

  day 1 and day 15

• Serum prealbumin

  Serum prealbumin was recorded through the blood routine test.(PA, g/L)

  day 1 and day 15

• Body Mass Index

  Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2

  day 1 and day 15

Secondary Outcomes (4)

• Depression

  day 1 and day 15

• Swallowing-Quality of Life questionnaire

  day 1 and day 15

• Functional Oral Intake Scale

  day 1 and day 15

• Penetration-Aspiration Scale

  day 1 and day 15

Study Arms (2)

The observation group

EXPERIMENTAL

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

Device: Intermittent Oral-esophageal Tube Feeding

The control group

ACTIVE COMPARATOR

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 NGT for enteral nutrition support

Device: nasogastric tube feeding

Interventions

Intermittent Oral-esophageal Tube Feeding DEVICE

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.

Also known as: Conventional care

The observation group

nasogastric tube feeding DEVICE

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.

Also known as: conventional care

The control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng da yi fu yuan hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Deglutition Disorders

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Nieto Luis, Doctor

  Site Coordinator of United Medical Group located in Miami

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 3, 2024
• Study Start: June 1, 2022
• Primary Completion: December 25, 2022
• Study Completion: December 31, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)