Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Pulsed Dye Laser for Treatment of Post Radiation Dysphonia

Conditions
-----------------
Oral Complications of Radiation Therapy, Stage I Laryngeal Cancer, Stage II Laryngeal Cancer

Intervention / Treatment
-----------------
* Procedure: laser therapy
* Other: questionnaire administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (pulsed dye laser)<br>Patients undergo pulsed dye laser monthly for three months. | Procedure: laser therapy<br>* Undergo pulsed dye laser<br>* Other names: therapy, laser;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Videostroboscopy rates | Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons. | Up to 6 months post-treatment | 
| Change in Voice Handicap Index (VHI)-10 score | The VHI-10 form will be scored and then those numbers will be compared pre and post treatment for each individual. | Baseline to 6 months post-treatment | 
| Change in jitter | Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics. | Baseline and at 6 months post-treatment | 
| Voice quality using the patient self-assessment questionnaire | 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. | Up to 6 months post-treatment | 
| Change in shimmer | Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics. | Baseline and at 6 months post-treatment | 
| Change in noise to harmonic ratio | Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics. | Baseline and at 6 months post-treatment | 
| Change in mean phonatory flow | Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics. | Baseline and at 6 months post-treatment |