Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Word intelligibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a new diagnosis of a T1/T2 tongue cancer
排除标准
- •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
研究组 & 干预措施
Prosthesis + Articulation Therapy
This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm
干预措施: Palatal Augmentation Prosthesis (PAP) (Device)
Prosthesis + Articulation Therapy
This arm will receive a PAP (palatal augmentation prosthesis) with standard articulation therapy. This is the study arm
干预措施: Articulation Therapy (Other)
No Prosthesis; Articulation Therapy Only
This arm will not receive a PAP (palatal augmentation prosthesis), but will receive standard articulation therapy. This is the control arm.
干预措施: Articulation Therapy (Other)
结局指标
主要结局
Word intelligibility
时间窗: 6 months
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.
次要结局
- Sentence intelligibility(6 months)
- Patient satisfaction with speech(6 months)
- Articulation at the word level of phonemes (consonant sounds)(6 months)
研究者
Stephanie M. Munz
Clinical Assistant Professor
University of Michigan