Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tongue Neoplasms
- Sponsor
- University of Michigan
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Word intelligibility
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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 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.
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.
Investigators
Stephanie M. Munz
Clinical Assistant Professor
University of Michigan
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
Outcomes
Primary Outcomes
Word intelligibility
Time Frame: 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. 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.
Secondary Outcomes
- Sentence intelligibility(6 months)
- Patient satisfaction with speech(6 months)
- Articulation at the word level of phonemes (consonant sounds)(6 months)