RECRUITING

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial

Quick Facts

Study Start:2018-01-02
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02584270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with a new diagnosis of a T1/T2 tongue cancer
  1. * Patients with recurrent disease
  2. * Patients with a history of prior head and neck radiation therapy
  3. * Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis

Contacts and Locations

Study Contact

Stephanie M Munz, DDS
CONTACT
734 936-8289
smmunz@med.umich.edu
Mary Burton
CONTACT
mjburt@med.umich.edu

Principal Investigator

Stephanie M Munz, DDS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Stephanie M Munz, DDS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-02
Study Completion Date2026-06

Study Record Updates

Study Start Date2018-01-02
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • palatal drop prosthesis

Additional Relevant MeSH Terms

  • Tongue Neoplasms
  • Tongue Cancer
  • Oral Cancer