NCT02584270 Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue
| NCT ID | NCT02584270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Tongue Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2018-01-02 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2018-01-02 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Stephanie M Munz, DDS
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT02584270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tongue Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02584270 currently recruiting?
Yes, NCT02584270 is actively recruiting participants. Contact the research team at smmunz@med.umich.edu for enrollment information.
Where is the NCT02584270 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT02584270 clinical trial?
NCT02584270 is sponsored by University of Michigan. The principal investigator is Stephanie M Munz, DDS at University of Michigan. The trial plans to enroll 40 participants.