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

NCT ID: NCT04112940

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-19
• Study Completion Date: 2021-03-30

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.

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.

Conditions

Deglutition Disorders; Oropharynx Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Starch-based Thickened Liquids

Intervention Type: OTHER

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

Intervention Type: OTHER

Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Nestle Resource ThickenUp; Nestle Resource ThickenUp Clear

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catriona Steele, PhD

Role: PRINCIPAL_INVESTIGATOR

KITE - Toronto Rehabilitation Institute, University Health Network

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R01DC011020

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CAPCR 16-5190 (NIH_HNC)

Identifier Type: OTHER

Identifier Source: secondary_id

16-5190

Identifier Type: -

Identifier Source: org_study_id