Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanessa Torrecillas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Pharyngeal Wall Augmentation Injection
Procedure/SurgeryParticipants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection. The procedure involves the submucosal injection of a biocompatible material into the posterior pharyngeal wall to improve velopharyngeal closure during speech and swallowing. Injection volume and technique will be determined by the treating clinician based on individual anatomy and functional assessment. All participants will undergo standardized assessments of speech intelligibility, nasalance, swallowing function, and patient-reported outcomes before and after the procedure. Timing: The procedure will occur once at the clinically indicated visit. Post-procedure assessments will be conducted at standardized follow-up intervals to evaluate functional outcomes
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Diagnostic with Possible Injection AugmentationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction
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.
Time frame
Baseline AssessmentSecondary outcomes
1
Accuracy of Nasometry for Identifying VPD
Proportion of participants with elevated nasalance scores (\>1 SD above normative mean) who also demonstrate VPD on flexible nasopharyngoscopy as determined by skilled rater.
Time frame
Baseline2
Nasometry Characterization of Velopharyngeal Dysfunction
Nasalance will be quantified using nasometry (percent resonance score). Higher values indicate greater hypernasality.
Time frame
Baseline, 6 weeks post injection3
Modified FEES Observation of Pharyngeal Residue and Nasal Regurgitation
Proportion of participants demonstrating residue or nasal regurgitation on modified FEES exam.
Time frame
Baseline, 6 weeks post injection4
Patient-Reported Communication Function
Change in total Speech Handicap Index (SHI) score
Time frame
Baseline, 6 weeks post injection, 6 months post injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanessa Torrecillas
Lead sponsor
University of Virginia
Sponsor institution
Source ClinicalTrials.gov