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

NCT04112940 | Completed Results

• 3 other identifiers: 16-51905R01DC011020CAPCR 16-5190 (NIH_HNC)
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deglutition Disorders; Oropharynx Cancer

Keywords

Swallowing

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (1)

• Number of Participants Reporting Dislike of Thickened Liquid Stimuli

  Baseline (single timepoint only)

Study Arms (1)

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.

Other: Starch-based Thickened Liquids; Other: Xanthan-gum Thickened Liquids

Interventions

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.

Also known as: Nestle Resource ThickenUp

Adults with oropharyngeal cancer

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.

Also known as: Nestle Resource ThickenUp Clear

Adults with oropharyngeal cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who have recently completed radiation treatment for oropharynx cancer at the University Health Network, Toronto.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Stomatognathic Diseases

Results Point of Contact

• Title: Director, Swallowing Rehabilitation Research Laboratory
• Organization: University Health Network

tri-swallowinglab@uhn.ca

4165973422

Study Officials

• Catriona Steele, PhD

  KITE - Toronto Rehabilitation Institute, University Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 2, 2019
• Study Start: December 19, 2016
• Primary Completion: December 31, 2019
• Study Completion: March 30, 2021
• Last Updated: April 7, 2023
• Results First Posted: July 13, 2022

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)