Pulsed Dye Laser for Treatment of Post Radiation Dysphonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Videostroboscopy rates
研究概览
简要总结
This pilot trial studies pulsed dye laser in treating patients with post radiation dysphonia. Dysphonia, or vocal cord scarring, can include trouble with the voice when trying to talk, such as hoarseness, change in voice pitch, and poor voice quality, and it commonly happens after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post radiation dysphonia.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the use of pulsed dye laser in treatment of the dysphonia that commonly results after radiation therapy for laryngeal carcinoma.
OUTLINE:
Patients undergo pulsed dye laser monthly for three months.
After completion of study treatment, patients are followed up at 1, 3, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from dysphonia after radiation therapy for glottic carcinoma will be included in the study
- •Patients will be included if their initial stage was T1 N0 M0 or T2 N0 M0
排除标准
- •Patients having previously undergone large surgical resections of the larynx or hypopharynx will be excluded
- •Patients fewer than 1 year out from completion of radiation therapy will be excluded
- •Patients with local disease recurrence would be excluded from the trial
- •Patients in whom the transnasal endoscope is poorly tolerated or patients in whom transnasal endoscopic laryngoscopy is contraindicated will be excluded
结局指标
主要结局
Videostroboscopy rates
时间窗: Up to 6 months post-treatment
Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.
Change in jitter
时间窗: Baseline and at 6 months post-treatment
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in shimmer
时间窗: Baseline and at 6 months post-treatment
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in mean phonatory flow
时间窗: Baseline and at 6 months post-treatment
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Change in noise to harmonic ratio
时间窗: Baseline and at 6 months post-treatment
Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
Voice quality using the patient self-assessment questionnaire
时间窗: Up to 6 months post-treatment
The post treatment questionnaire form will be scored and then comparisons made for each individual question on the form across our study group. These values will be discrete variables.
Change in Voice Handicap Index (VHI)-10 score
时间窗: Baseline to 6 months post-treatment
The VHI-10 form will be scored and then those numbers will be compared pre and post treatment for each individual.
次要结局
未报告次要终点