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NCT07264036 · ClinicalTrials.gov registry record · NA
Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
A NA study of Head and Neck Cancer and Survivorship, sponsored by Vanessa Torrecillas.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07264036: Recruiting NA study of Head and Neck Cancer and Survivorship, sponsored by Vanessa Torrecillas.
NCT07264036 is a NA study of Head and Neck Cancer and Survivorship that is actively recruiting participants, run by Vanessa Torrecillas. The registered enrollment target is 20 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07264036, a NA study of Head and Neck Cancer and Survivorship, is actively recruiting participants, sponsored by Vanessa Torrecillas.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 fea
Conditions Studied
Interventions
- PROCEDURE Pharyngeal Wall Augmentation Injection
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2027-07-01 |
| Phase | NA |
What NCT07264036 shows while recruiting
NCT07264036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (92% lower).
The record links to 5 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Pharyngeal Wall Augmentation Injection is the first listed.
NCT07264036 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT07264036 about?
NCT07264036 is a clinical study titled "Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study". 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...
What is the current status of trial NCT07264036?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2026-01-01. Estimated completion is 2027-07-01.
What conditions does trial NCT07264036 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Survivorship, Dysphagia, Speech Disorder, Velopharyngeal Insufficiency.
What interventions are being tested in trial NCT07264036?
The interventions under investigation include: Pharyngeal Wall Augmentation Injection (PROCEDURE).
Who is sponsoring clinical trial NCT07264036?
This trial is sponsored by Vanessa Torrecillas, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07264036 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07264036's enrollment target sits among peer trials
20 219th of 250 higher than 29 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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