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

University Health Network, Toronto

Status: Completed

Conditions: Oropharynx Cancer; Deglutition Disorders

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04112940

16-5190

CAPCR 16-5190 (NIH_HNC) (Other Identifier)

5R01DC011020 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

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.

Treatment:

Other: Starch-based Thickened Liquids

Other: Xanthan-gum Thickened Liquids