Pharyngeal Wall Augmentation for Speech Disorder

Overseen By Elena Squire, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanessa Torrecillas

Disqualifiers: Non-cancer VPD, Intensive cancer surveillance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method to assist individuals with speech and swallowing issues following head and neck cancer. The researchers aim to determine if a treatment involving Pharyngeal Wall Augmentation Injection, which plumps up the back of the throat, can alleviate these problems. The trial includes tests to understand the prevalence and severity of this condition and to evaluate new diagnostic tools. Suitable candidates are adults who speak English, have undergone head and neck cancer treatment, and continue to experience a nasal-sounding voice. Participants should not have other causes for their speech issues or require further throat treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance quality of life for many.

What prior data suggests that pharyngeal wall augmentation is safe for improving speech and swallowing in head and neck cancer survivors?

Research shows that pharyngeal wall augmentation, a procedure to address speech and swallowing issues, is generally well-tolerated. Studies have found that this procedure can effectively improve speech problems like hypernasality, where speech sounds too nasal. This is particularly beneficial for individuals with velopharyngeal dysfunction (VPD), a condition causing difficulties with speech and swallowing.

While any medical procedure carries risks, current evidence suggests that complications are rare for this treatment. The procedure is minimally invasive, meaning it doesn’t involve major surgery, making it a safer option for those seeking relief from VPD-related symptoms.

Overall, the safety profile for pharyngeal wall augmentation is positive, with studies supporting its use for improving speech and swallowing. Participants considering this option can feel reassured by the existing data on its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharyngeal wall augmentation for speech disorders because it offers a targeted solution for individuals with velopharyngeal dysfunction (VPD). Unlike traditional therapies that might involve speech therapy or surgical interventions, this treatment involves a minimally invasive injection that directly addresses the structural issue causing the disorder. By augmenting the pharyngeal wall, it aims to improve speech intelligibility and reduce nasalance, potentially offering quicker and more precise results. This approach could represent a significant advancement in how we treat structural causes of speech disorders.

What evidence suggests that pharyngeal wall augmentation is effective for improving speech and swallowing in VPD?

Research has shown that injections to the back of the throat can improve speech and swallowing for people with velopharyngeal dysfunction (VPD). In this trial, participants will undergo a standardized evaluation, and a subset with confirmed VPD may choose to receive a pharyngeal wall augmentation injection. One study found that these injections reduced nasal-sounding speech in patients with moderate VPD. Another study showed that they also made speech clearer and swallowing easier for adults with VPD. The treatment adds volume to the back wall of the throat, helping to close the gap between the soft palate and throat. This closure is crucial for better speech and swallowing, which can enhance the quality of life for head and neck cancer survivors. ^{1 2 3 6 7}

Who Is on the Research Team?

Vanessa Torrecillas, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for head and neck cancer survivors who are experiencing velopharyngeal dysfunction, which can cause nasal speech, swallowing difficulties, and reduced quality of life. Participants must be able to undergo various assessments including physical exams and swallowing evaluations.

Inclusion Criteria

I am 18 or older and speak English.

I had head or neck cancer and was treated with surgery and/or chemoradiation.

My voice sounds very nasal according to a doctor's evaluation.

Exclusion Criteria

I have no upcoming surgeries or treatments on my throat that would affect my trial participation.

I have no medical reasons preventing throat surgery.

I need closer monitoring for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Diagnostic Assessment

Participants undergo a multidisciplinary evaluation including physical examination, flexible nasolaryngoscopy, acoustic speech analysis, nasometry, clinical swallowing assessment, and FEES.

Baseline

1 visit (in-person)

Treatment

A subset of participants with confirmed VPD may receive pharyngeal wall augmentation injections.

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in speech intelligibility, nasalance, swallowing function, and patient-reported outcomes.

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pharyngeal Wall Augmentation Injection

Trial Overview The study tests whether pharyngeal wall augmentation injections can improve speech intelligibility and swallowing function in patients with velopharyngeal dysfunction. It includes a thorough assessment of the prevalence, severity, and impact of VPD using advanced diagnostic tools.

How Is the Trial Designed?

Group I: Diagnostic with Possible Injection Augmentation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Vanessa Torrecillas

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7061665/

Assessment of outcomes and complications of posterior ... The authors believe that augmenting the posterior pharyngeal wall with dermal fat graft is effective in improving hypernasality in patients with moderate ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07264036

Velopharyngeal Dysfunction in Head & Neck Cancer ... Aim 3: Evaluate the effectiveness of pharyngeal wall augmentation injections for improving speech intelligibility and swallowing function.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/lary.31788

Efficacy of Posterior Pharyngeal Wall Injection for ... In this article, we describe the impact of posterior pharyngeal wall (PPW) injection augmentation in adult patients with velopharyngeal ...

4. link.springer.com link.springer.com/article/10.1007/s00405-025-09767-1

Characterizing the safety and efficacy of injection ... There are four main categories of surgical intervention for VPI: augmentation of the posterior pharyngeal wall (including injection ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681522000225

Posterior pharyngeal wall augmentation using autologous ... The aim of this study was to retrospectively estimate intervention outcomes and to establish suitable indications for autogenous tiered cartilage ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587621001312

Metanalysis of alloplastic materials versus autologous fat ... Injection pharyngoplasty offers a minimally invasive alternative intervention for treatment of VPI secondary to small velopharyngeal gaps.

7. emedicine.medscape.com emedicine.medscape.com/article/994975-treatment

Velopharyngeal Dysfunction Treatment & Management Although these procedures appear to be safe and relatively easy to perform, critical evaluation of procedures for posterior-wall augmentation ...