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

Oral Cancer Clinical Trial

— PGSRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02584270
• Other study ID #: HUM00093723.1
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Stephanie M Munz, DDS
• Phone: 734 936-8289
• Email: smmunz[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a new diagnosis of a T1/T2 tongue cancer

Exclusion Criteria:

• Patients with recurrent disease

• Patients with a history of prior head and neck radiation therapy

• Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis

Related Conditions & MeSH terms

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

Intervention

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 associated articulation therapy are necessary for this therapy to be effective.

Other:
• Articulation Therapy
Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.

Locations

Country	Name	City	State
United States	University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Word intelligibility	The Assessment of Intelligibility of Dysarthric speech (AIDS) test is a validated assessment of word and sentence intelligibility as well as speech efficiency and will be measured at baseline before surgery for tongue cancer, then after surgery at one month, three months, six months and one year. Six months is the primary time point measurement. Measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of separate un-related words.	6 months
Secondary	Sentence intelligibility	The Assessment of intelligibility of dysarthric speech (AIDS) test is a validated assessment of word and sentence intelligibility as well as speech efficiency and will be measured at baseline before surgery for tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of words in sentences.	6 months
Secondary	Articulation at the word level of phonemes (consonant sounds)	The Goldman Fristoe 2 test of Articulation sounds in words subtest (GFTA2) is a standardized, validated and reliable tool that systematically assesses articulation of phonemes (consonant sounds). It offers normative data from ages 2 through 21. This will be measured at baseline pre-treatment of tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured is the raw score generated from the test.	6 months
Secondary	Patient satisfaction with speech	The Speech Handicap Index (SHI) is designed to evaluate an individual's speech function and corresponding psycho-social factors. This will be measured at baseline pre-treatment of tongue cancer, then post-operatively at one month, three months, six months and one year. Six months is the primary time point measurement, although measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured is the mean score of the survey.	6 months