Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

N/ACompletedNCT02198131

Wake Forest University Health Sciences9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Oral Complications of Radiation Therapy Stage I Laryngeal Cancer Stage II Laryngeal Cancer

Interventions

laser therapyPROCEDURE

Undergo pulsed dye laser

questionnaire administrationOTHER

Ancillary studies

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Videostroboscopy rates

Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.

Time frame: 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.

Time frame: Baseline to 6 months post-treatment

Change in jitter

Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.

Time frame: 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.

Time frame: Up to 6 months post-treatment

Change in shimmer

Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and at 6 months post-treatment

Data from ClinicalTrials.gov

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