- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04112940
Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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:
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Unsafe Swallowing
Time Frame: Baseline (single timepoint only)
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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.
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Baseline (single timepoint only)
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Amount of Residue in the Pharynx
Time Frame: Baseline (single timepoint only)
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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).
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Baseline (single timepoint only)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Reporting Dislike of Thickened Liquid Stimuli
Time Frame: Baseline (single timepoint only)
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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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Baseline (single timepoint only)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-5190
- 5R01DC011020 (U.S. NIH Grant/Contract)
- CAPCR 16-5190 (NIH_HNC) (Other Identifier: UHN Research Ethics Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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