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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tongue Neoplasms, Tongue Cancer, Oral Cancer

Intervention / Treatment
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* Device: Palatal Augmentation Prosthesis (PAP)
* Other: Articulation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthesis + Articulation Therapy<br>This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm. | Device: Palatal Augmentation Prosthesis (PAP)<br>* 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.<br>Other: Articulation Therapy<br>* Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.<br>* Other names: Speech Therapy;|
| Other: No Prosthesis; Articulation Therapy Only<br>This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm. | Other: Articulation Therapy<br>* Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.<br>* Other names: Speech Therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palatal drop prosthesis