Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palatal Augmentation Prosthesis (PAP), Articulation Therapy.
- Who it may be relevant to
- Registry conditions: Tongue Neoplasms, Tongue Cancer, Oral Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
Overview
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.
Interventions
- Device Palatal Augmentation Prosthesis (PAP)
The palatal augmentation prosthesis, or PAP can improve speech and swallowing functions through reshaping the palatal contours. This may improve the contact between the tongue and hard palate as a person speaks or eats. It is meant to be created after adequate healing in patients with adequate motivation for improvements in their speech and swallowing. Regular wear and articulation therapy are necessary for this therapy to be effective. - Other Articulation Therapy
Subjects will receive the standard of care speech and articulation therapy in either arm.
Primary outcome measures
- Word intelligibility [Time frame: 6 months]
Secondary outcome measures (3)
- Sentence intelligibility [Time frame: 6 months]
- Articulation at the word level of phonemes (consonant sounds) [Time frame: 6 months]
- Patient satisfaction with speech [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry — Ann Arbor
Identifiers
NCT: NCT02584270 · HUM00093723.1