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

Not Applicable

Recruiting

• Conditions: Tongue Cancer; Oral Cancer; Tongue Neoplasms
• Interventions: Device: Palatal Augmentation Prosthesis (PAP); Other: Articulation Therapy

• Registration Number: NCT02584270
• Lead Sponsor: University of Michigan

Brief 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.

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 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.

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Study Start: 2018-01-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prosthesis + Articulation Therapy	Articulation Therapy	This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.
No Prosthesis; Articulation Therapy Only	Articulation Therapy	This arm will not receive a palatal augmentation prosthesis, but will receive standard articulation therapy, and is the control arm.
Prosthesis + Articulation Therapy	Palatal Augmentation Prosthesis (PAP)	This arm will receive a palatal augmentation prosthesis with standard articulation therapy, and is the study arm.

Primary Outcome Measures

Name	Time	Method
Word intelligibility	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Sentence intelligibility	6 months	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.
Patient satisfaction with speech	6 months	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.
Articulation at the word level of phonemes (consonant sounds)	6 months	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.

Trial Locations

Locations (1)

University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry; 🇺🇸 Ann Arbor, Michigan, United States