Status:

COMPLETED

Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Conditions:

Deglutition Disorders

Oropharynx Cancer

Eligibility:

All Genders

18-100 years

Brief Summary

This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing. The focus of this study is...

Detailed Description

Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). However, the field lacks a clear understanding of how liquids of different consistencies behave during swa...

Eligibility Criteria

Inclusion

  • An initial cancer diagnosis of cancer in the base of tongue region of the oropharynx (Tumor staging T2,T3 \& T4; Nodal staging N0 orN1; Human Papilloma Virus + or -).
  • Completion of bilateral radiation therapy to the neck 3 months prior to enrollment
  • No longer requiring primary enteral feeding for nutrition.

Exclusion

  • Prior history of swallowing, motor speech, gastro#esophageal difficulties, chronic sinusitis or taste disturbance.
  • Previous radiation to the head and neck (prior to current illness);
  • Previous cancer diagnosis;
  • Prior or planned neck dissection;
  • Trachestomy in situ;
  • Neurological difficulties unrelated to spinal disorder (e.g. Stroke, Parkinson disease, etc).
  • Cognitive communication difficulties that may hinder ability to participate.
  • Current use of mechanical ventilation
  • Type 1 Diabetes (due to the requirement to swallow stimuli containing starch based thickeners, which carry a significant carbohydrate load).
  • Known allergies to latex, food coloring or dental glue (due to the probability that these items will come into contact with the oral mucosa during data collection).
  • Occupational exposure to radiation exceeding 10 mSv in the past 6 months.
  • Current pregnancy.

Key Trial Info

Start Date :

December 19 2016

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 30 2021

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT04112940

Start Date

December 19 2016

End Date

March 30 2021

Last Update

April 7 2023

Active Locations (1)

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University Health Network

Toronto, Ontario, Canada, M5G 2C4