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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Palatal Augmentation Prosthesis (PAP)
  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.
• Другое Articulation Therapy
  Subjects will receive the standard of care speech and articulation therapy in either arm.

Первичные конечные точки

• Word intelligibility [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Sentence intelligibility [Срок оценки: 6 months]
• Articulation at the word level of phonemes (consonant sounds) [Срок оценки: 6 months]
• Patient satisfaction with speech [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry — Ann Arbor

Идентификаторы

NCT: NCT02584270 · HUM00093723.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗