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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04112940
Enrollment
12
Registered
2019-10-02
Start date
2016-12-19
Completion date
2021-03-30
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders, Oropharynx Cancer

Keywords

Swallowing

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.

Interventions

OTHERStarch-based Thickened Liquids

Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.

Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Unsafe SwallowingBaseline (single timepoint only)Swallowing safety was measured using the Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels \> 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (\< 3 vs \>/= 3). We will report the frequency (count) of participants showing scores \> 2 by bolus consistency.
Amount of Residue in the PharynxBaseline (single timepoint only)Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. In healthy swallowing, residue is expected to be minimal. We report mean values and standard deviations for amount of residue by consistency (thin, slightly thick, and mildly thick liquids).

Secondary

MeasureTime frameDescription
Number of Participants Reporting Dislike of Thickened Liquid StimuliBaseline (single timepoint only)Participants rated the palatability of lemon flavored water and liquid barium stimuli in slightly thick, mildly thick and moderately thick consistencies. Palatability was scored using a 9-point hedonic categorical rating system previously described by Pelletier et al. The ratings use 9 descriptors to capture the degree to which a participant likes a stimulus, with anchors of Dislike extremely and Like extremely. Scores of 1-4 indicate liking of a stimulus, a score of 5 is neutral while scores of 6-9 indicate dislike. We dichotomized this scale between scores of 1-4 (liking) and scores of 5-9 and report the number of participants reporting scores of 6-9 (dislike).

Countries

Canada

Participant flow

Participants by arm

ArmCount
Adults With Oropharyngeal Cancer
Adult participants who have completed radiation therapy for oropharyngeal cancer within the past 3 months.
12
Total12

Baseline characteristics

CharacteristicAdults With Oropharyngeal Cancer
Age, Continuous63 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
10 Participants
Region of Enrollment
Canada
12 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 12
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

Primary

Amount of Residue in the Pharynx

Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. In healthy swallowing, residue is expected to be minimal. We report mean values and standard deviations for amount of residue by consistency (thin, slightly thick, and mildly thick liquids).

Time frame: Baseline (single timepoint only)

Population: Adult participants who had completed radiation therapy for oropharyngeal cancer within the past 3 months. A sample of 12 adults was enrolled. The thickened consistencies were only administered (and analyzed) for the 6 participants who displayed unsafe swallowing on the thin liquid stimuli.

ArmMeasureValue (MEAN)Dispersion
Thin Liquid BariumAmount of Residue in the Pharynx2.5 % of the squared C2-C4 length scalarStandard Deviation 2.7
Slightly Thick Liquid BariumAmount of Residue in the Pharynx3.3 % of the squared C2-C4 length scalarStandard Deviation 2.8
Mildly Thick Liquid BariumAmount of Residue in the Pharynx4.2 % of the squared C2-C4 length scalarStandard Deviation 3.1
Primary

Number of Participants With Unsafe Swallowing

Swallowing safety was measured using the Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels \> 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (\< 3 vs \>/= 3). We will report the frequency (count) of participants showing scores \> 2 by bolus consistency.

Time frame: Baseline (single timepoint only)

Population: Adult participants who had completed radiation therapy for oropharyngeal cancer within the past 3 months. A sample of 12 adults was enrolled. The thickened consistencies were only administered (and analyzed) for the 6 participants who displayed obvious unsafe swallowing on the thin liquid stimuli during data collection. A further 3 participants were determined to have shown unsafe swallowing on thin liquids during post-hoc analysis, but this was not recognized at the time of data collection.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Thin Liquid BariumNumber of Participants With Unsafe Swallowing9 Participants
Slightly Thick Liquid BariumNumber of Participants With Unsafe Swallowing4 Participants
Mildly Thick Liquid BariumNumber of Participants With Unsafe Swallowing3 Participants
Secondary

Number of Participants Reporting Dislike of Thickened Liquid Stimuli

Participants rated the palatability of lemon flavored water and liquid barium stimuli in slightly thick, mildly thick and moderately thick consistencies. Palatability was scored using a 9-point hedonic categorical rating system previously described by Pelletier et al. The ratings use 9 descriptors to capture the degree to which a participant likes a stimulus, with anchors of Dislike extremely and Like extremely. Scores of 1-4 indicate liking of a stimulus, a score of 5 is neutral while scores of 6-9 indicate dislike. We dichotomized this scale between scores of 1-4 (liking) and scores of 5-9 and report the number of participants reporting scores of 6-9 (dislike).

Time frame: Baseline (single timepoint only)

Population: Adult participants who had completed radiation therapy for oropharyngeal cancer within the past 3 months. A sample of 12 participants was enrolled. However, only 7 participants completed the palatability testing component of the study.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Thin Liquid BariumNumber of Participants Reporting Dislike of Thickened Liquid Stimuli2 Participants
Slightly Thick Liquid BariumNumber of Participants Reporting Dislike of Thickened Liquid Stimuli3 Participants
Mildly Thick Liquid BariumNumber of Participants Reporting Dislike of Thickened Liquid Stimuli3 Participants
Mildly Thick Liquid BariumNumber of Participants Reporting Dislike of Thickened Liquid Stimuli5 Participants
Moderately Thick Lemon Flavored WaterNumber of Participants Reporting Dislike of Thickened Liquid Stimuli4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026