Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia

Oral Complications of Radiation Therapy Clinical Trial

Official title:

Pulsed Dye Laser for Treatment of Post Radiation Dysphonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198131
• Other study ID #: IRB00011092
• Secondary ID: NCI-2014-01458CC
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: June 2016

Study information

• Verified date: April 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dysphonia
• Laryngeal Neoplasms
• Oral Complications of Radiation Therapy
• Stage I Laryngeal Cancer
• Stage II Laryngeal Cancer

Intervention

Procedure:
• laser therapy
Undergo pulsed dye laser

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Videostroboscopy rates	Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.	Up to 6 months post-treatment
Primary	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
Primary	Change in jitter	Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.	Baseline and at 6 months post-treatment
Primary	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
Primary	Change in shimmer	Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.	Baseline and at 6 months post-treatment
Primary	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
Primary	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