Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study

Deglutition Disorders Clinical Trial

Official title:

Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112940
• Other study ID #: 16-5190
• Secondary ID: 5R01DC011020CAPC
• Status: Completed
• Start date: December 19, 2016
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 30, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Head and Neck Neoplasms
• Oropharyngeal Neoplasms
• Oropharynx Cancer

Intervention

Other:
• Starch-based Thickened Liquids
Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
• Xanthan-gum Thickened Liquids
Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline (single timepoint only)
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).	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).	Baseline (single timepoint only)