Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT)

University of Michigan

Status: Enrolling

Conditions: Oral Cancer; Tongue Cancer; Tongue Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02584270

HUM00093723.1

Details and patient eligibility

About

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.

Full description

This study will randomize patients into two arms; one for oral cancer patients that receive a small device, similar to a denture, called a PAP. The other arm will be patients who serve as a control and will not receive a PAP.

The PAP requires patients to have a dental mold created. A dentist customizes the PAP to specifically fit the individual's mouth.

The study will investigate whether the PAP improves speech following tongue cancer as measured by three different scales. Both groups will see a speech language therapist for additional measures of speech evaluation.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Prosthesis + Articulation Therapy

Experimental group

Description:

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

Treatment:

Other: Articulation Therapy

Device: Palatal Augmentation Prosthesis (PAP)

No Prosthesis; Articulation Therapy Only

Other group

Description:

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

Treatment:

Other: Articulation Therapy