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

Oral Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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 in 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 on their 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 with the device.

Clinical Trial 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 are a control and who will not receive a PAP.

The PAP requires patients to have a dental mold created. A dentist customizes the PAP to fit their 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 to have their speech evaluated. ;

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cancer
• Tongue Cancer
• Tongue Neoplasms

• NCT number: NCT02584270
• Study type: Interventional
• Source: University of Michigan
• Contact: Stephanie M Munz, DDS
• Phone: 734 936-8289
• Email: smmunz@med.umich.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2018
• Completion date: June 2026