Detecting the Changes of Swallowing Function in Oral Cancer Patients

November 16, 2025 updated by: National Taiwan University Hospital

Using High Resolution Impedance Manometry (HRIM) Combined With Videofluoroscopic Swallow Study (VFSS) to Investigate the Changes of Swallowing Function in Oral Cancer Patients

The evidence of swallowing changes in oral cancer patients is still limited. This study aimed to investigated the swallowing changes in these patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: to investigated the swallowing changes in oral cancer patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).

Methods: 1. patients are fulfilled tongue cancer diagnosis; 2.they will undergo VFSS and HRIM examinations before or after surgery if they experience discomfort while swallowing.

Study Type

Observational

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with the diagnosis of oral cancer

Description

Inclusion Criteria:

  • patients elective received oral cancer surgery

Exclusion Criteria:

  • 1. patients had major underlying disease, ex: heart, brain, lung, liver disease
  • 2. coagulopathy
  • 3.pregnancy
  • 4. the patients could not have good compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental: pull through group
the patients receiving the pull though method during the tongue cancer surgery
Procedure: pull through group
pull through method
Placebo Comparator: mandibular-lip split group
the patients receiving the traditional mandibular lip split method during the tongue cancer surgery
Procedure: mandibular-lip split group
traditional mandibular-lip split method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bolus presence time
Time Frame: 15 minutes during the examination
Lower value indicates shorter bolus presence in the pharynx
15 minutes during the examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

June 10, 2025

Study Completion (Actual)

June 11, 2025

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Estimated)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101035RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ethical concerns

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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