Clinical trial NCT04112940: Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
Official title: Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Oropharynx Cancer
Keywords: Swallowing
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2019-10-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who have recently completed radiation treatment for oropharynx cancer at the University Health Network, Toronto.

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 to evaluate the flow of liquids of varying consistency in the head and neck cancer population.

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 swallowing. In order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx.

This study explores this question in individuals who have undergone radiation treatment for head and neck cancer, specifically located in the oropharynx.

Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, and mildly thick) using commercially available food thickeners. Swallowing will be observed under videofluoroscopy.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Unsafe Swallowing
timeFrame: Baseline (single timepoint only)
measure: Amount of Residue in the Pharynx
timeFrame: Baseline (single timepoint only)
Secondary outcomes:
measure: Number of Participants Reporting Dislike of Thickened Liquid Stimuli
timeFrame: Baseline (single timepoint only)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: KITE - Toronto Rehabilitation Institute, University Health Network
name: Catriona Steele, PhD
role: PRINCIPAL_INVESTIGATOR
References: