Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
Qualifiers
Patients with a new diagnosis of a T1/T2 tongue cancer
Disqualifiers
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
Trial design
Treatments tested in this trial
- Palatal Augmentation Prosthesis (PAP)
- Articulation Therapy
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov