Clinical trial · Observational
Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
NCT04112940CI-TRIAL-00065427completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deglutition Disorders | — | UNRESOLVED | — |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Starch-based Thickened Liquids | Other | — | UNRESOLVED |
| Xanthan-gum Thickened Liquids | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults with oropharyngeal cancer
- description
- 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.
- interventionNames
- Other: Starch-based Thickened Liquids
- Other: Xanthan-gum Thickened Liquids
Primary outcomes (2)
- measure
- Number of Participants With Unsafe Swallowing
- timeFrame
- Baseline (single timepoint only)
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.