NCT02584270

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality post-surgery. This is a robust scientific randomized prospective clinical trial. Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion of the tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing, is not routinely provided.

Detailed description

This study will randomize patients into two arms; one for oral cancer patients that receive a small device, similar to a denture, called a PAP. The other arm will be patients who serve as a control and will not receive a PAP. The PAP requires patients to have a dental mold created. A dentist customizes the PAP to specifically fit the individual's mouth. The study will investigate whether the PAP improves speech following tongue cancer as measured by three different scales. Both groups will see a speech language therapist for additional measures of speech evaluation.

Conditions

• Tongue Neoplasms
• Tongue Cancer
• Oral Cancer

Interventions

Type	Name	Description
DEVICE	Palatal Augmentation Prosthesis (PAP)	The palatal augmentation prosthesis, or PAP can improve speech and swallowing functions through reshaping the palatal contours. This may improve the contact between the tongue and hard palate as a person speaks or eats. It is meant to be created after adequate healing in patients with adequate motivation for improvements in their speech and swallowing. Regular wear and articulation therapy are necessary for this therapy to be effective.
OTHER	Articulation Therapy	Subjects will receive the standard of care speech and articulation therapy in either arm.

Timeline

• Start date: 2018-01-02
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2015-10-22
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States