NCT06301763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

March 4, 2024

Last Update Submit

June 13, 2024

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (5)

  • Hemoglobin Level

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

    day 1 and day 15

  • Serum albumin Level

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

    day 1 and day 15

  • Total serum protein Level

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

    day 1 and day 15

  • Serum prealbumin Level

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

    day 1 and day 15

  • Body Mass Index Level

    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)

Intermittent Oral-esophageal Tube Feeding

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 health condition. The observation group receives IOE for enteral nutrition support.54 cm.

Device: Intermittent Oral-esophageal Tube Feeding

nasogastric tube feeding

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 health condition.The control group receives NGT for enteral nutrition support

Device: nasogastric tube feeding

Interventions

Intermittent Oral-esophageal Tube FeedingDEVICE

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.

Intermittent Oral-esophageal Tube Feeding
nasogastric tube feedingDEVICE

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.

nasogastric tube feeding

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years.
  • With the history of Nasopharyngeal Carcinoma 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afli Hospital

Zhongguo, China

Location

Related Publications (1)

  • Zeng H, Zhao W, Zhang X, Wang X, Luo P, Li H, Wang L, Zeng X. How enteral nutrition modes influence nasopharyngeal carcinoma survivors with late dysphagia after radiotherapy: a randomized controlled study. Support Care Cancer. 2024 Oct 5;32(10):702. doi: 10.1007/s00520-024-08912-6.

    PMID: 39367230DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Nieto Luis, Master

    Site Coordinator of United Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

January 1, 2023

Primary Completion

December 11, 2023

Study Completion

December 31, 2023

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)