Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

Pulsed Dye Laser for Treatment of Post Radiation Dysphonia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02198131

Enrollment

Registered

2014-07-23

Start date

2009-10-31

Completion date

2016-06-30

Last updated

2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDURElaser therapy

Undergo pulsed dye laser

OTHERquestionnaire administration

Ancillary studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Videostroboscopy rates	Up to 6 months post-treatment	Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.
Change in Voice Handicap Index (VHI)-10 score	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.
Change in jitter	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	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 shimmer	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	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	Baseline and at 6 months post-treatment	Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026