Injectable Augmentation Outcomes in Post-Radiation Head and Neck Cancer Patients With Velopharyngeal Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction
研究概览
简要总结
Some head and neck cancer survivors develop velopharyngeal dysfunction (VPD), a problem with closure between the soft palate and throat that can cause nasal-sounding speech, food or liquid leaking into the nose, difficulty swallowing, and reduced quality of life. This study aims to better understand VPD in this population and to evaluate whether pharyngeal wall augmentation (plumping up the back wall of the throat) can improve speech and swallowing.
Participants will undergo a multidisciplinary assessment including physical examination, flexible nasolaryngoscopy, speech recording and acoustic analysis, nasometry, clinical swallowing evaluation, and fiberoptic endoscopic evaluation of swallowing (FEES).
Aim 1: Determine the prevalence, severity, and functional impact of VPD in head and neck cancer survivors.
Aim 2: Assess the feasibility and usefulness of advanced diagnostic tools for VPD.
The investigators hypothesize that high nasalance scores (>1 SD above normal) will accurately predict VPD with at least 75% positive predictive value and will correlate with worse communication-related quality of life (CPIB).
The investigators also hypothesize that participants with VPD will have more pharyngeal residue or nasal regurgitation on FEES, and that these findings will be associated with lower swallowing-related quality of life (SWAL-QOL).
Aim 3: Evaluate the effectiveness of pharyngeal wall augmentation injections for improving speech intelligibility and swallowing function.
The investigators expect that this treatment will lead to measurable changes in both objective assessments and patient-reported outcomes. The results will help improve diagnosis and management of VPD in head and neck cancer survivors.
详细描述
Velopharyngeal dysfunction (VPD) is a disorder in which the soft palate and posterior pharyngeal wall do not close adequately during speech and swallowing. Head and neck cancer (HNC) survivors may develop VPD as a result of neuromuscular impairment from surgical resection and/or radiation therapy. Consequences include hypernasal speech from nasal air escape, nasopharyngeal residue during swallowing, nasal regurgitation, and reductions in speech and swallowing-related quality of life. Despite its clinical relevance, VPD in HNC survivors is under-recognized, and evidence regarding optimal diagnostic methods and effective interventions remains limited. This study aims to characterize VPD in this population, evaluate the diagnostic utility of advanced assessment tools, and assess the therapeutic effect of pharyngeal wall augmentation.
Overview This is a prospective study using a multidisciplinary, multimodal assessment protocol to evaluate speech and swallowing function in HNC survivors with suspected or confirmed VPD. Participants will undergo standardized clinical, instrumental, and patient-reported outcome assessments. A subset of participants with confirmed VPD will receive pharyngeal wall augmentation as part of standard clinical care, allowing for pre- and post-intervention comparison.
Aim 1: Characterization of VPD in HNC Survivors
Describe the prevalence, severity, and functional impact of VPD in this population. Participants will complete a comprehensive evaluation including:
Oropharyngeal physical examination to identify structural or neuromuscular contributors to impaired velopharyngeal closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking adults (≥18 years) History of head and neck cancer treated with surgical resection, chemoradiation, or both Presence of perceptual hypernasality on clinical assessment
排除标准
- •Pre-existing or suspected non-cancer-related causes of velopharyngeal dysfunction Contraindications to pharyngeal wall augmentation Requirement for more intensive active cancer surveillance Planned future surgical or medical treatments to the pharynx that would interfere with participation
研究组 & 干预措施
Diagnostic with Possible Injection Augmentation
All participants will undergo a standardized, multidisciplinary evaluation including physical examination, flexible nasolaryngoscopy, acoustic speech analysis, nasometry, clinical swallowing assessment, and fiberoptic endoscopic evaluation of swallowing (FEES). A subset of participants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection as part of standard-of-care treatment. All participants, regardless of whether they receive the injection, will have pre-assessment data collected to evaluate speech intelligibility, nasalance, swallowing function, and patient-reported outcomes. The patients who undergo the pharyngeal augmentation injection will also have post-assessment data collected. No formal comparison between participants who do and do not receive the injection will be performed; all data will be analyzed individually.
干预措施: Pharyngeal Wall Augmentation Injection (Procedure)
结局指标
主要结局
Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction
时间窗: Baseline Assessment
Feasibility will be reported as the percentage of enrolled participants with complete, usable nasometry and FEES data at baseline. Data quality will be defined by the proportion of recordings meeting predefined technical standards for interpretation. Additional exploratory analyses will examine correlations between nasometry and FEES findings and clinical reference standards (perceptual speech ratings, SHI and SWAL-QOL scores), but correlation statistics will not be used as outcome units for feasibility reporting.
次要结局
- Accuracy of Nasometry for Identifying VPD(Baseline)
- Change in Patient Reported Swallowing-Related Quality of Life(Baseline, 6 months post injection, 6 months post injection)
- Nasometry Characterization of Velopharyngeal Dysfunction(Baseline, 6 weeks post injection)
- Modified FEES Observation of Pharyngeal Residue and Nasal Regurgitation(Baseline, 6 weeks post injection)
- Patient-Reported Communication Function(Baseline, 6 weeks post injection, 6 months post injection)
研究者
Vanessa Torrecillas
Assistant Professor of Otolaryngology - Head & Neck Surgery
University of Virginia