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 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 morbidity of oral cancer therapy, namely speech and swallowing function in a population of patients with T1/T2 tumors of the tongue who are not currently routinely recommended for a palatal augmentation prosthesis.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 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: Jennifer A Lay-Luskin, MPhil, CCRC; Email: jalay@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: Jennifer A Lay-Luskin, MPhil, CCRC; Email: jalay@med.umich.edu
      • Contact: Stephanie Munz, DDS; Phone Number: 734-936-8289; Email: smmunz@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 palatal augmentation prosthesis with standard articulation therapy, and is the study arm.	Device: Palatal Augmentation Prosthesis (PAP); The palatal augmentation prosthesis improves speech and swallowing function through reshaping the palatal contours in order to obtain contact of the tongue to the hard palate during function. It is intended to be fabricated 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.; Other Names: Speech Therapy
Other: No Prosthesis; Articulation Therapy Only; This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm.	Other: Articulation Therapy; Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.; 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 and 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 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
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 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 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
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
Tongue to palate contact	The Complete Speech Electropalatometer with Electropalatogram (EPG) offers objective data in which to measure baseline contact of the tongue to the palate as well as changes over time. 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 percentage of data points recorded during speech function.	6 months

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: palatal drop prosthesis
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Tongue Diseases; Mouth Neoplasms; Tongue Neoplasms
• 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