University Health Network
Toronto, Ontario, M5G 2C4, Canada
NCT Number: NCT04112940
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.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Observational
Toronto, Ontario, M5G 2C4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
Other names: Nestle Resource ThickenUp
Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
Other names: Nestle Resource ThickenUp Clear
Time frame: Baseline (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.
Time frame: 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).
Time frame: Baseline (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).
University Health Network, Toronto
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03916809
Deglutition Disorders, Digestive System Diseases
Milwaukee, Wisconsin, United States
View Trial DetailsNCT07726667
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Gaziantep, Gaz, Turkey (Türkiye)
View Trial DetailsNCT02170506
Deglutition Disorders, Digestive System Diseases
Rouen, France
View Trial DetailsNCT05439447
Deglutition Disorders, Digestive System Diseases
Seongnam-si, Gyeonggi-do, South Korea
View Trial Details