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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Cancer; Tongue Cancer; Tongue Neoplasms
• Intervention / Treatment: Device: Palatal Augmentation Prosthesis (PAP); Other: Articulation Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie M Munz, DDS; Phone Number: 734 936-8289; Email: smmunz@med.umich.edu
• Study Contact Backup: Name: Mary Burton; Email: mjburt@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry
      • Contact: Stephanie Munz, DDS; Phone Number: 734-936-8289; Email: smmunz@med.umich.edu
      • Contact: Mary Burton; Email: mjburt@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prosthesis + Articulation Therapy; This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm	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.; Other Names: Speech Therapy
Other: No Prosthesis; Articulation Therapy Only; This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm.	Other: Articulation Therapy; Subjects will receive the standard of care speech and articulation therapy in either arm.; Other Names: Speech Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The AIDS score will be measured at baseline before surgery for tongue cancer, then after surgery at the timepoints of 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Stephanie M Munz, DDS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimated): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: palatal drop prosthesis
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Tongue Diseases; Mouth Neoplasms; Tongue Neoplasms; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Speech Therapy
• Other Study ID Numbers: HUM00093723.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No