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

Primary Purpose

Tongue Neoplasms, Tongue Cancer, Oral Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palatal Augmentation Prosthesis (PAP)
Articulation Therapy
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tongue Neoplasms focused on measuring palatal drop prosthesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Department of Oral and Maxillofacial Surgery and Hospital DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Prosthesis + Articulation Therapy

No Prosthesis; Articulation Therapy Only

Arm Description

This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.

This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 20, 2015
Last Updated
April 21, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02584270
Brief Title
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue
Acronym
PGSRT
Official Title
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue Neoplasms, Tongue Cancer, Oral Cancer
Keywords
palatal drop prosthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prosthesis + Articulation Therapy
Arm Type
Experimental
Arm Description
This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.
Arm Title
No Prosthesis; Articulation Therapy Only
Arm Type
Other
Arm Description
This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm.
Intervention Type
Device
Intervention Name(s)
Palatal Augmentation Prosthesis (PAP)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Articulation Therapy
Other Intervention Name(s)
Speech Therapy
Intervention Description
Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.
Primary Outcome Measure Information:
Title
Word intelligibility
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Sentence intelligibility
Description
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.
Time Frame
6 months
Title
Articulation at the word level of phonemes (consonant sounds)
Description
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.
Time Frame
6 months
Title
Patient satisfaction with speech
Description
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.
Time Frame
6 months
Title
Tongue to palate contact
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie M Munz, DDS
Phone
734 936-8289
Email
smmunz@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer A Lay-Luskin, MPhil, CCRC
Email
jalay@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie M Munz, DDS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Munz, DDS
Phone
734-936-8289
Email
smmunz@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Jennifer A Lay-Luskin, MPhil, CCRC
Email
jalay@med.umich.edu

12. IPD Sharing Statement

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

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