RecruitingNot ApplicableNCT07264036

Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study

Injectable Augmentation Outcomes in Post-Radiation Head and Neck Cancer Patients With Velopharyngeal Dysfunction


Sponsor

Vanessa Torrecillas

Enrollment

20 participants

Start Date

Mar 24, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a small pilot study looking at a voice problem called velopharyngeal dysfunction — when the soft palate doesn't close properly, causing speech to sound overly nasal. It affects some patients after head and neck cancer treatment. The study is exploring whether a procedure to add bulk to the back of the throat wall can help. **You may be eligible if...** - You are an English-speaking adult (18 or older) - You have a history of head and neck cancer treated with surgery, radiation, chemotherapy, or a combination - A healthcare provider has assessed that your speech sounds excessively nasal (hypernasality) **You may NOT be eligible if...** - Your speech problem existed before your cancer or is caused by something unrelated to cancer - You have medical reasons why the throat-bulking procedure cannot be done - You are still undergoing intensive cancer monitoring or plan to have additional surgery or treatment to your throat area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPharyngeal Wall Augmentation Injection

Participants 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


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT07264036


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