Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study

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.

Flexible nasolaryngoscopy to assess closure patterns during speech and swallowing tasks.

Acoustic speech analysis and objective measures of speech intelligibility.

Nasometry to quantify nasalance and the degree of hypernasality.

Clinical swallowing evaluation, documenting perceptual indicators of safety and efficiency.

Fiberoptic Endoscopic Evaluation of Swallowing (FEES) to visualize bolus flow, pharyngeal residue, and nasal regurgitation.

Patient-reported outcomes will include the Speech Handicap Index (SHI) and the Swallowing Quality of Life Questionnaire (SWAL-QOL). These measures will characterize functional limitations associated with VPD.

Aim 2: Feasibility and Utility of Advanced Diagnostic Tools Aim 2a: Nasometry as a Diagnostic Indicator This component evaluates whether nasalance scores can reliably identify VPD. The primary hypothesis is that nasalance values \>1 standard deviation above normative means will demonstrate a positive predictive value ≥75% when compared with endoscopic confirmation. Correlations will be assessed between nasalance and SHI scores to determine whether acoustic measures reflect patient-perceived communication limitations.

Aim 2b: FEES Indicators of VPD and Functional Correlates

This component assesses whether swallowing abnormalities on FEES are associated with VPD. Participants with confirmed VPD are expected to exhibit:

increased pharyngeal residue, and/or nasal regurgitation during bolus presentation.

These findings will be correlated with SWAL-QOL scores to determine whether FEES characteristics reflect functional swallowing impairment. Results may support FEES as a useful adjunctive tool in evaluating the impact of VPD on swallowing physiology.

Aim 3: Efficacy of Pharyngeal Wall Augmentation Participants with confirmed VPD who are clinically indicated for treatment will undergo pharyngeal wall augmentation using standard-of-care techniques. Injection material and volume will be determined by treating clinicians. The intervention is intended to reduce the velopharyngeal gap and improve closure during speech and swallowing.

Outcome Measures

Pre- and post-intervention comparisons will include:

Nasalance scores Acoustic speech parameters and overall intelligibility Perceptual ratings of speech resonance FEES findings (pharyngeal residue, nasal regurgitation) Patient-reported outcomes (SHI, SWAL-QOL) Participant-reported impressions of change

The primary hypothesis is that pharyngeal wall augmentation will result in measurable improvement in both objective assessments and patient-reported function.

Significance

This study will provide:

A comprehensive description of VPD in HNC survivors. Evidence on the diagnostic value of nasometry and FEES for identifying clinically meaningful VPD.

Prospective data on the functional impact of pharyngeal wall augmentation. Findings will inform best practices for the diagnosis and management of VPD in HNC survivors and support the development of multidisciplinary clinical pathways for improving communication and swallowing outcomes.

• Accuracy of Nasometry for Identifying VPD [Time frame: Baseline]
• Nasometry Characterization of Velopharyngeal Dysfunction [Time frame: Baseline, 6 weeks post injection]
• Modified FEES Observation of Pharyngeal Residue and Nasal Regurgitation [Time frame: Baseline, 6 weeks post injection]
• Patient-Reported Communication Function [Time frame: Baseline, 6 weeks post injection, 6 months post injection]
• Change in Patient Reported Swallowing-Related Quality of Life [Time frame: Baseline, 6 months post injection, 6 months post injection]