Rehabilitation for speech after tongue cancer surgery using a prosthesis
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
This study is testing if a special mouthpiece can help people who had tongue cancer surgery speak and swallow better compared to those who don’t use it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT02584270 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a palatal augmentation prosthesis (PAP) in improving speech and swallowing functions in patients who have undergone surgery for T1/T2 tongue cancer. Patients will be randomly assigned to receive either the PAP or serve as a control group without the device. The study aims to fill a gap in current knowledge regarding post-surgical rehabilitation for oral cancer patients. Speech evaluations will be conducted using multiple scales to assess the impact of the PAP on communication abilities.
Who should consider this trial
Good fit: Ideal candidates are patients newly diagnosed with T1/T2 tongue cancer requiring surgical intervention.
Not a fit: Patients with recurrent disease, prior head and neck radiation therapy, or inadequate dental support for the prosthesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance speech and swallowing functions for patients recovering from tongue cancer surgery.
How similar studies have performed: While the use of prostheses in oral rehabilitation is established, this specific approach with the PAP is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie M Munz, DDS — University of Michigan
- Study coordinator: Stephanie M Munz, DDS
- Email: smmunz@med.umich.edu
- Phone: 734 936-8289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.