Trial Outcomes & Findings for Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study (NCT NCT04112940)

Last Updated: 2023-04-07

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

12 participants

Primary outcome timeframe

Baseline (single timepoint only)

Results posted on

2023-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Adults With Oropharyngeal Cancer Adult participants who had completed radiation therapy for oropharyngeal cancer within the past 3 months who underwent a swallowing x-ray study in which they swallowed liquid stimuli prepared to different consistencies.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults With Oropharyngeal Cancer n=12 Participants Adult participants who have completed radiation therapy for oropharyngeal cancer within the past 3 months.
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thin Liquid Barium n=12 Participants Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder and water.	Slightly Thick Liquid Barium n=6 Participants Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder, water and Nestle Resource ThickenUp Clear thickener.	Mildly Thick Liquid Barium n=6 Participants Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder, water and Nestle Resource ThickenUp Clear thickener.	Mildly Thick Liquid Barium Bracco E-Z-Paque barium prepared in 20% w/v concentration and mixed with water and Nestle Resource ThickenUp Clear thickener to a mildly thick consistency.	Moderately Thick Lemon Flavored Water Lemon flavored water mixed with Nestle Resource ThickenUp clear thickener to a moderately thick consistency.
Number of Participants With Unsafe Swallowing	9 Participants	4 Participants	3 Participants	—	—

PRIMARY outcome

Timeframe: Baseline (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).

Outcome measures

Outcome measures
Measure	Thin Liquid Barium n=12 Participants Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder and water.	Slightly Thick Liquid Barium n=6 Participants Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder, water and Nestle Resource ThickenUp Clear thickener.	Mildly Thick Liquid Barium n=6 Participants Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder, water and Nestle Resource ThickenUp Clear thickener.	Mildly Thick Liquid Barium Bracco E-Z-Paque barium prepared in 20% w/v concentration and mixed with water and Nestle Resource ThickenUp Clear thickener to a mildly thick consistency.	Moderately Thick Lemon Flavored Water Lemon flavored water mixed with Nestle Resource ThickenUp clear thickener to a moderately thick consistency.
Amount of Residue in the Pharynx	2.5 % of the squared C2-C4 length scalar Standard Deviation 2.7	3.3 % of the squared C2-C4 length scalar Standard Deviation 2.8	4.2 % of the squared C2-C4 length scalar Standard Deviation 3.1	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Thin Liquid Barium n=7 Participants Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder and water.	Slightly Thick Liquid Barium n=7 Participants Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder, water and Nestle Resource ThickenUp Clear thickener.	Mildly Thick Liquid Barium n=7 Participants Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque barium powder, water and Nestle Resource ThickenUp Clear thickener.	Mildly Thick Liquid Barium n=7 Participants Bracco E-Z-Paque barium prepared in 20% w/v concentration and mixed with water and Nestle Resource ThickenUp Clear thickener to a mildly thick consistency.	Moderately Thick Lemon Flavored Water n=7 Participants Lemon flavored water mixed with Nestle Resource ThickenUp clear thickener to a moderately thick consistency.
Number of Participants Reporting Dislike of Thickened Liquid Stimuli	2 Participants	3 Participants	3 Participants	5 Participants	4 Participants

Adverse Events

Adults With Oropharyngeal Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Swallowing Rehabilitation Research Laboratory

University Health Network

Phone: 4165973422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place