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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DC011020 | U.S. NIH Grant/Contract | View source | |
| CAPCR 16-5190 (NIH_HNC) | Other Identifier | UHN Research Ethics Board |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with oropharyngeal cancer | Adult participants who have completed radiation therapy for oropharyngeal cancer within the past 3 months will undergo a swallowing x-ray study in which they will swallow up to 15 liquid stimuli prepared to different consistencies using starch and gum based thickeners. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Starch-based Thickened Liquids | Other | Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (single timepoint only) |
| 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). | Baseline (single timepoint only) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Adults who have recently completed radiation treatment for oropharynx cancer at the University Health Network, Toronto.
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| Name | Affiliation | Role |
|---|---|---|
| Catriona Steele, PhD | KITE - Toronto Rehabilitation Institute, University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
No plan at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults With Oropharyngeal Cancer | Adult participants who have completed radiation therapy for oropharyngeal cancer within the past 3 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (single timepoint only) |
|
1 week post data collection
Participants experiencing any discomfort during or after participating in data collection were asked to report these to the study team. These were then reviewed for relatedness and seriousness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults With Oropharyngeal Cancer | Adult participants who have completed radiation therapy for oropharyngeal cancer within the past 3 months will undergo a swallowing x-ray study in which they will swallow liquid stimuli prepared to different consistencies. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Swallowing Rehabilitation Research Laboratory | University Health Network | 4165973422 | 7802 | tri-swallowinglab@uhn.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2017 | May 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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|
| Xanthan-gum Thickened Liquids | Other | Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test. |
|
|
| Baseline (single timepoint only) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Thin Liquid Barium | 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. |
| OG001 | Slightly Thick Liquid Barium | 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. |
| OG002 | Mildly Thick Liquid Barium | 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. |
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | % of the squared C2-C4 length scalar | Baseline (single timepoint only) |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | Baseline (single timepoint only) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D010038 | Otorhinolaryngologic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009057 | Stomatognathic Diseases |