Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Unsafe Swallowing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Participants With Unsafe Swallowing
时间窗: Baseline (single timepoint only)
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.
Amount of Residue in the Pharynx
时间窗: Baseline (single timepoint only)
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).
次要结局
- Number of Participants Reporting Dislike of Thickened Liquid Stimuli(Baseline (single timepoint only))