N/A
N=12
Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
Deglutition Disorders · Oropharynx Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04112940 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Number of Participants With Unsafe Swallowing — 9; 4; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Starch-based Thickened Liquids (Other); Xanthan-gum Thickened Liquids (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Unsafe Swallowing |
9; 4; 3 | — |
| PRIMARY Amount of Residue in the Pharynx |
2.5; 3.3; 4.2 | — |
| SECONDARY Number of Participants Reporting Dislike of Thickened Liquid Stimuli |
2; 3; 3; 5; 4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04112940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.