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

NCT02584270 | Recruiting DMC

• 1 other identifier: HUM00093723.1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tongue Neoplasms; Tongue Cancer; Oral Cancer

Keywords

palatal drop prosthesis

Outcome Measures

Primary Outcomes (1)

• Word intelligibility

  The Assessment of Intelligibility of Dysarthric speech (AIDS) test is a validated assessment of word and sentence intelligibility as well as speech efficiency. The AIDS score will be measured at baseline before surgery for tongue cancer, then after surgery at the timepoints of one month, three months, six months and one year. Six months is the primary time point measurement. Measurements will also be obtained at these other time points, which will possibly be used for other outcome analysis which are neither primary nor secondary. The unit being measured will be a percent score of words correctly transcribed by two blinded untrained listeners of the subjects' audio recordings of separate un-related words.

  6 months

Secondary Outcomes (3)

• Sentence intelligibility

  6 months

• Articulation at the word level of phonemes (consonant sounds)

  6 months

• Patient satisfaction with speech

  6 months

Study Arms (2)

Prosthesis + Articulation Therapy

EXPERIMENTAL

This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm

Device: Palatal Augmentation Prosthesis (PAP); Other: Articulation Therapy

No Prosthesis; Articulation Therapy Only

OTHER

This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm.

Other: Articulation Therapy

Interventions

Palatal Augmentation Prosthesis (PAP) DEVICE

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.

Prosthesis + Articulation Therapy

Articulation Therapy OTHER

Subjects will receive the standard of care speech and articulation therapy in either arm.

Also known as: Speech Therapy

No Prosthesis; Articulation Therapy Only; Prosthesis + Articulation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a new diagnosis of a T1/T2 tongue cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Tongue Neoplasms; Mouth Neoplasms

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Stephanie M Munz, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie M Munz, DDS

CONTACT

734 936-8289; smmunz@med.umich.edu

Mary Burton

CONTACT

mjburt@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: January 2, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (1)